510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963902Substantially Equivalent

Quantitative Fibrinogen Assay

Ortho Diagnostic Systems, Inc., Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963902 is the FDA 510(k) clearance record for QUANTITATIVE FIBRINOGEN ASSAY, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code GIS (Test, Fibrinogen). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K963902.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GIS Test, Fibrinogen
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
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