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

Name: FDA 510(k) clearance K984138
Creator: U.S. Food and Drug Administration
Published: 1999-03-23

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.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1998-11-18
Decision date: 1999-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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