Cleared Traditional

BIOTEST ANTI-EBV RECOMBINANT, EA IGM

K983842 · Biotest Diagnostics Corp. · Microbiology
Jun 1999
Decision
222d
Days
Class 1
Risk

About This 510(k) Submission

K983842 is an FDA 510(k) clearance for the BIOTEST ANTI-EBV RECOMBINANT, EA IGM, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Biotest Diagnostics Corp. (Denville, US). The FDA issued a Cleared decision on June 9, 1999, 222 days after receiving the submission on October 30, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K983842 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1998
Decision Date June 09, 1999
Days to Decision 222 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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