510(k) Report

510(k) · Cleared

Cleared

Antigen Control Cells

K801507510(k) TraditionalCleared Aug 20, 198051-day reviewClass II21 CFR 866.3510

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

Ortho Diagnostics, Inc. · GOL Antigen, Ha (Including Ha Control), Rubella

Cleared on Aug 20, 1980 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 20, 1980
Review
51 days
Class
Class II
Product code
GOL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801507Source: FDA 510(k) database · How lineage is built

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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.

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  • 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All GOL devices

GOL Antigen, Ha (Including Ha Control), Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GOL

FDA has decided no GOL device since 2007.

Median 510(k) review, days · GOL

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

Recalls per year · GOL

No recall names GOL since 2007.

Adverse event reports per year · GOL

30in 2009

2009: 30
2007high 30 (2009) · low 0 (2007)2025

MAUDE reports naming product code GOL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—030
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 Ortho Diagnostics, Inc.

24 FDA decisions under this applicant name. See the company

  • K802404Ortho Bovine Albumin Solution 30% ProteOrtho Diagnostics, Inc. · 1980
  • K800357BI-Level Assayed Card. Drug Cont., I,IIOrtho Diagnostics, Inc. · 1980
  • K800310Ortho Antisera ControlOrtho Diagnostics, Inc. · 1980
  • K791791Ortho Antibody Enhancement SolutionOrtho Diagnostics, Inc. · 1979
  • K791301Ortho TSH Ria KitOrtho Diagnostics, Inc. · 1979

Recent decisions in GOL

The GOL category page

  • K841174Rubella Antibody FluoroimmunoassayIntl. Diagnostic Technology · 1984
  • K834032Rubaquick Diagnostic KitAbbott Laboratories · 1984
  • K810309Rubella Antibodies Test ReagentsCalbiochem-Behring Corp. · 1981
  • K802508Rubelisa Igm Test KitM.A. Bioproducts · 1980
  • K802102Rubella Elisa Reagents Rubella Igg AntiCalbiochem-Behring Corp. · 1980

https://510kreport.com/device/K801507 · printed Nov 6, 2026

Cite this page

510(k) Report. “K801507: Antigen Control Cells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801507

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