510(k) Report

510(k) · Cleared

Cleared

Gilford Tri-Level Assayed Immunology Control

K851202510(k) TraditionalCleared Apr 29, 198534-day reviewClass II21 CFR 866.5240

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gilford · DAK Complement C1q, Antigen, Antiserum, Control

Cleared on Apr 29, 1985 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 29, 1985
Review
34 days
Class
Class II
Product code
DAK
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK851202 Gilford Tri-Level Assayed Immunology ControlGilford · 1985
  2. Descendant · cites it directly · 0 of its ownK984045 RF Control for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1999
  3. Descendant · cites it directly · 0 of its ownK983130 Liquid Immunology Controls for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1998
  4. Descendant · cites it directly · 0 of its ownK983241 Aso/CRP/RF Controls for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1998

Most influential descendants

Showing 3 of 3 · See all
  • K984045RF Control for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1999 · cites it directly0descendants
  • K983130Liquid Immunology Controls for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1998 · cites it directly0descendants
  • K983241Aso/CRP/RF Controls for Immunoturbidimetric AssaysKamiya Biomedical Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851202Gilford Tri-Level Assayed Immunology ControlGilford1985—
+1K984045RF Control for Immunoturbidimetric AssaysKamiya Biomedical Co.1999—
+1K983130Liquid Immunology Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.1998—
+1K983241Aso/CRP/RF Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
FIG. 1 — Lineage of K851202, 1985–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984045RF Control for Immunoturbidimetric AssaysKamiya Biomedical Co.19990
K983130Liquid Immunology Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.19980
K983241Aso/CRP/RF Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.19980

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K984045 (Kamiya Biomedical Co., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DAK devices

DAK Complement C1q, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DAK

FDA has decided no DAK device since 2007.

Median 510(k) review, days · DAK

Too few DAK 510(k)s in any year since 2007 to give a median.

Recalls per year · DAK

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DAK

No MAUDE report names DAK since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Gilford

10 FDA decisions under this applicant name. See the company

  • K853465Gilford Immunoglobulin G ReagentGilford · 1985
  • K853467Gilford Immunoglobulin a ReagentGilford · 1985
  • K853466Gilford C3 Complement ReagentGilford · 1985
  • K853469Gilford Immunoglobulin M ReagentGilford · 1985
  • K853468Gilford C4 Complement ReagentGilford · 1985

Recent decisions in DAK

The DAK category page

  • K031563Bindazyme CLQ Cic Eia KitThe Binding Site, Ltd. · 20031 recall
  • K032254Ibl C1Q-Cic Cia TestIbl GmbH · 2003
  • K012576Cic-C1Q EiaAmerican Laboratory Products Co., Ltd. · 2002
  • K973203Thymostat Elisa for the Detection of Human Igg,M and a Anti-Rabbit Igg AntibodiesSangstat Medical Corp. · 1998
  • K972873Immustrip Hama IggImmunomedics, Inc. · 1998

https://510kreport.com/device/K851202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K851202: Gilford Tri-Level Assayed Immunology Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851202

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026