THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH— 510(k) K984133

Name: FDA 510(k) clearance K984133
Creator: U.S. Food and Drug Administration
Published: 1999-01-11

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K984133 for THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH, Substantially Equivalent on 1999-01-11. Applicant: Zeus Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LLM
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1998-11-18
Decision date: 1999-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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