510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972772Substantially Equivalent

Esp Culture System II - Myco Susceptibility Testing

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

K972772 is the FDA 510(k) clearance record for ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING, a class II device, cleared for Trek Diagnostic Systems, Inc. on under FDA product code MJA (Susceptibility Test Powders, Antimycobacterial). FDA records list 68 510(k) clearances for Trek Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K972772.

Clearance record

Decision date
Received
(719 days to decision)
Product code
MJA Susceptibility Test Powders, Antimycobacterial
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Trek Diagnostic Systems, Inc. 29299 Clemens Rd. Suite 1-K, Westlake OH
510(k) summary
Statement
Third party review
No

Clearances, product code MJA

Trailing 12 months

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

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