510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900377Substantially Equivalent

College of Amer Path. Refer. Prep. for Fibrinogen

Baxter Healthcare Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900377 is the FDA 510(k) clearance record for COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN, a class II device, cleared for Baxter Healthcare Corp on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K900377.

Clearance record

Decision date
Received
(39 days to decision)
Product code
JPA System, Multipurpose For In Vitro Coagulation Studies
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Baxter Healthcare Corp P.O.Box 520672, Miami FL
Third party review
No

Clearances, product code JPA

Trailing 12 months
1 clearance under product code JPA in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JPA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260