APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM— 510(k) K984138

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K984138 for APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM, Substantially Equivalent on 1999-03-23. Applicant: Zeus Scientific, Inc..

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1998-11-18
Decision date: 1999-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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