Cleared Traditional

ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING

K972772 · Trek Diagnostic Systems, Inc. · Microbiology

Jul 1999

Decision

719d

Days

Class 2

Risk

About This 510(k) Submission

K972772 is an FDA 510(k) clearance for the ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING, a Susceptibility Test Powders, Antimycobacterial (Class II — Special Controls, product code MJA), submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on July 13, 1999, 719 days after receiving the submission on July 24, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K972772 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 1997
Decision Date	July 13, 1999
Days to Decision	719 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement