ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.— 510(k) K904268

Name: FDA 510(k) clearance K904268
Creator: U.S. Food and Drug Administration
Published: 1990-11-13

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K904268 for ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM., Substantially Equivalent on 1990-11-13. 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: 1990-09-18
Decision date: 1990-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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