510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940209Substantially Equivalent

Ortho Assayed Reference Plasma-Normal/ Plasma-Abnormal

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

K940209 is the FDA 510(k) clearance record for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K940209.

Clearance record

Decision date
Received
(482 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
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 GGN

Trailing 12 months

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

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