510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885076Substantially Equivalent

Coag-a-Mate Xc/xc Plus Version D.00 Software

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885076 is the FDA 510(k) clearance record for COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE, a class II device, cleared for Organon Teknika Corp. on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K885076.

Clearance record

Decision date
Received
(22 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
Organon Teknika Corp. 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code JPA

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