IMMUNOWELL LYME (P39 RECOMBINANT) TEST— 510(k) K911599

Name: FDA 510(k) clearance K911599
Creator: U.S. Food and Drug Administration
Published: 1991-12-30

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K911599 for IMMUNOWELL LYME (P39 RECOMBINANT) TEST, Substantially Equivalent on 1991-12-30. Applicant: General Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-04-09
Decision date: 1991-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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