VISTA ANTIGEN BRUCELLA ABORTUS— 510(k) K972394

Name: FDA 510(k) clearance K972394
Creator: U.S. Food and Drug Administration
Published: 1997-08-25

Substantially Equivalent

Lee Laboratories, Inc.

FDA 510(k) clearance K972394 for VISTA ANTIGEN BRUCELLA ABORTUS, Substantially Equivalent on 1997-08-25. Applicant: Lee Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Lee Laboratories, Inc.
Product code: Code GSO
Device class: Class 2
Regulation: 21 CFR 866.3085
Advisory panel: Microbiology
Date received: 1997-06-26
Decision date: 1997-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayson, GA, US

Download summary PDF View on FDA.gov ↗

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K972389 — VISTA ANTIGEN SALMONELLA H D1997-08-25
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