SYPHILIS BIO-ENZABEAD KIT— 510(k) K820934

Name: FDA 510(k) clearance K820934
Creator: U.S. Food and Drug Administration
Published: 1982-06-10

Substantially Equivalent

Biometics Laboratory Products

FDA 510(k) clearance K820934 for SYPHILIS BIO-ENZABEAD KIT, Substantially Equivalent on 1982-06-10. Applicant: Biometics Laboratory Products. Device class: 2.

Clearance details

Applicant: Biometics Laboratory Products
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1982-04-02
Decision date: 1982-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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