510(k) K965129— BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

Substantially Equivalent

Wampole Laboratories

Clearance details

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

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