510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983244Substantially Equivalent

Sensititre 18-24 Hr Susceptibility Plates(addition of Meropenem)

Trek Diagnostic Systems, Ltd., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983244 is the FDA 510(k) clearance record for SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM), a class I device, cleared for Trek Diagnostic Systems, Inc. on under FDA product code JTW (System, Transport, Aerobic). FDA records list 68 510(k) clearances for Trek Diagnostic Systems, Inc., from to . As of , FDA records show 9 recalls naming K983244.

Clearance record

Decision date
Received
(75 days to decision)
Product code
JTW System, Transport, Aerobic
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Trek Diagnostic Systems, Inc. 982 Keynote Cir., Suite 6, Cleveland OH
510(k) summary
Statement
Third party review
No

Clearances, product code JTW

Trailing 12 months

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

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