510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911745Substantially Equivalent

Simplate Pediatric

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

K911745 is the FDA 510(k) clearance record for SIMPLATE PEDIATRIC, a class II device, cleared for Organon Teknika Corp. on under FDA product code JCA (Device, Bleeding Time). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K911745.

Clearance record

Decision date
Received
(113 days to decision)
Product code
JCA Device, Bleeding Time
Regulation
21 CFR 864.6100
Device class
Class II
Review panel
Hematology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Statement
Third party review
No

Clearances, product code JCA

Trailing 12 months

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

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