STAPH-A-LEX(TM) SYSTEM— 510(k) K926173

Name: FDA 510(k) clearance K926173
Creator: U.S. Food and Drug Administration
Published: 1993-08-10

Substantially Equivalent

Trinity Laboratories, Inc.

FDA 510(k) clearance K926173 for STAPH-A-LEX(TM) SYSTEM, Substantially Equivalent on 1993-08-10. Applicant: Trinity Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-12-08
Decision date: 1993-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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