IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC— 510(k) K964487

Name: FDA 510(k) clearance K964487
Creator: U.S. Food and Drug Administration
Published: 1997-02-07

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K964487 for IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, Substantially Equivalent on 1997-02-07. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1996-11-07
Decision date: 1997-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

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