STREP-SURE A/E— 510(k) K941111

Name: FDA 510(k) clearance K941111
Creator: U.S. Food and Drug Administration
Published: 1994-08-02

Substantially Equivalent

Clinical Standards Laboratories, Inc.

FDA 510(k) clearance K941111 for STREP-SURE A/E, Substantially Equivalent on 1994-08-02. Applicant: Clinical Standards Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Standards Laboratories, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1994-03-07
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, US

Download summary PDF View on FDA.gov ↗

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