GEN-PROBE BETA-LACTAMASE TEST KIT— 510(k) K870422

Name: FDA 510(k) clearance K870422
Creator: U.S. Food and Drug Administration
Published: 1987-04-21

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K870422 for GEN-PROBE BETA-LACTAMASE TEST KIT, Substantially Equivalent on 1987-04-21. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-02-03
Decision date: 1987-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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