510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901327Substantially Equivalent

Ortho Correction Reagents

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

K901327 is the FDA 510(k) clearance record for ORTHO CORRECTION REAGENTS, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code GJT (Plasma, Coagulation Factor Deficient). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K901327.

Clearance record

Decision date
Received
(65 days to decision)
Product code
GJT Plasma, Coagulation Factor Deficient
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
Third party review
No

Clearances, product code GJT

Trailing 12 months

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

FDA records show no clearances under product code GJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJT, 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