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
K955638Substantially Equivalent

Synthafax Aptt Reagent

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

K955638 is the FDA 510(k) clearance record for SYNTHAFAX APTT REAGENT, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code GFO (Activated Partial Thromboplastin). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show one recall naming K955638.

Clearance record

Decision date
Received
(134 days to decision)
Product code
GFO Activated Partial Thromboplastin
Regulation
21 CFR 864.7925
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 GFO

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