510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860031Substantially Equivalent

Gen Diagnostics' Imipenem 10 Mcg Susceptibity Disk

bioMerieux, Inc., Morris Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860031 is the FDA 510(k) clearance record for GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK, a class II device, cleared for Organon Teknika Corp. on under FDA product code JTT (Susceptibility Test Powders, Antimicrobial). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K860031.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JTT Susceptibility Test Powders, Antimicrobial
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Organon Teknika Corp. 201 Tabor Rd., Morris Plains NJ
Third party review
No

Clearances, product code JTT

Trailing 12 months

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

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