510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923921Substantially Equivalent

Il Test Pt Fibrinogen Hs

Instrumentation Laboratory Co., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923921 is the FDA 510(k) clearance record for IL TEST PT FIBRINOGEN HS, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code GIS (Test, Fibrinogen). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K923921.

Clearance record

Decision date
Received
(82 days to decision)
Product code
GIS Test, Fibrinogen
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
510(k) summary
Summary
Third party review
No

Clearances, product code GIS

Trailing 12 months

FDA records hold no clearances under product code GIS in the trailing twelve months.

FDA records show no clearances under product code GIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260