GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST— 510(k) K924715

Name: FDA 510(k) clearance K924715
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K924715 for GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST, Substantially Equivalent on 1994-03-11. 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: 1992-09-21
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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