ACCUPACE GROUP A STREPTOCOCCUS ID TEST— 510(k) K915852

Name: FDA 510(k) clearance K915852
Creator: U.S. Food and Drug Administration
Published: 1992-04-02

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K915852 for ACCUPACE GROUP A STREPTOCOCCUS ID TEST, Substantially Equivalent on 1992-04-02. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code MDK
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1991-12-27
Decision date: 1992-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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