Cleared Traditional

EBV-VCA ANTIBODY ASSAY KIT

K821849 · Biotech Research Laboratories, Inc. · Microbiology

Aug 1982

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K821849 is an FDA 510(k) clearance for the EBV-VCA ANTIBODY ASSAY KIT, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Biotech Research Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1982, 50 days after receiving the submission on June 23, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K821849 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1982
Decision Date	August 12, 1982
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—