ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.— 510(k) K902213

Name: FDA 510(k) clearance K902213
Creator: U.S. Food and Drug Administration
Published: 1990-08-06

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K902213 for ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA., Substantially Equivalent on 1990-08-06. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code MCS
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1990-05-16
Decision date: 1990-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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