BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM— 510(k) K965131

Name: FDA 510(k) clearance K965131
Creator: U.S. Food and Drug Administration
Published: 1997-03-26

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K965131 for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, Substantially Equivalent on 1997-03-26. Applicant: Wampole Laboratories. Device class: 2.

Clearance details

Applicant: Wampole Laboratories
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1996-12-23
Decision date: 1997-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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