510(k) Report

510(k) · Cleared

Cleared

Plasma Fibrinogen Control Level 1/Level 2

K935598510(k) TraditionalCleared May 2, 1995529-day reviewClass II21 CFR 864.7340

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

Clinical Controls, Inc. · GIL Plasma, Fibrinogen Control

Cleared on May 2, 1995 after a 529-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 2, 1995
Review
529 days
Class
Class II
Product code
GIL
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K935598Source: 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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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 GIL devices

GIL Plasma, Fibrinogen Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIL

FDA has decided no GIL device since 2007.

Median 510(k) review, days · GIL

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

Recalls per year · GIL

No recall names GIL since 2007.

Adverse event reports per year · GIL

No MAUDE report names GIL since 2007.

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

17 FDA decisions under this applicant name. See the company

  • K964278Whole Blood Glucose Control Level 1,2,and 3/Whole Blood Glucose Linearity Control-LEVEL1,2,3,4,5,and 6Clinical Controls, Inc. · 1996
  • K962432Liquispex Urine (Micro)Albumin ControlClinical Controls, Inc. · 1996
  • K955691Serum Volatiles Control Level 1 & 2Clinical Controls, Inc. · 1996
  • K955690Aqueous Ethanol/Ammonia Control Level 1, 2, & 3Clinical Controls, Inc. · 1996
  • K946265Fibrinogen High Abnormal Control - Level 3Clinical Controls, Inc. · 1995

Recent decisions in GIL

The GIL category page

  • K962407N/T Protein Control PYBehring Diagnostics, Inc. · 1996
  • K946265Fibrinogen High Abnormal Control - Level 3Clinical Controls, Inc. · 1995
  • K946193Fibrinogen Control (Human) Level 1, 2, 3More Diagnostics · 1995
  • K951012N/T Protein Control PYBehring Diagnostics, Inc. · 1995
  • K934741Liquid Fibrinogen FDP Control Level 1 & 2Clinical Controls, Inc. · 1994

https://510kreport.com/device/K935598 · printed Nov 5, 2026

Cite this page

510(k) Report. “K935598: Plasma Fibrinogen Control Level 1/Level 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935598

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