510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895392Substantially Equivalent

Antimicrobial Susceptibility Disk

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

K895392 is the FDA 510(k) clearance record for ANTIMICROBIAL SUSCEPTIBILITY DISK, a class II device, cleared for Organon Teknika Corp. on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K895392.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code JTN

Trailing 12 months
5 clearances under product code JTN in the twelve months to November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260
November 20260