BIOTEST ANTI-EBV RECOMBINANT, EA IGM— 510(k) K983842

Name: FDA 510(k) clearance K983842
Creator: U.S. Food and Drug Administration
Published: 1999-06-09

Substantially Equivalent

Biotest Diagnostics Corp.

FDA 510(k) clearance K983842 for BIOTEST ANTI-EBV RECOMBINANT, EA IGM, Substantially Equivalent on 1999-06-09. Applicant: Biotest Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Biotest Diagnostics Corp.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1998-10-30
Decision date: 1999-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denville, NJ, US

Download summary PDF View on FDA.gov ↗

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