Cleared Traditional

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT

K853484 · Biotech Research Laboratories, Inc. · Microbiology

Feb 1986

Decision

169d

Days

Class 1

Risk

About This 510(k) Submission

K853484 is an FDA 510(k) clearance for the INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT, a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP), submitted by Biotech Research Laboratories, Inc. (Rockville, US). The FDA issued a Cleared decision on February 5, 1986, 169 days after receiving the submission on August 20, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number	K853484 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1985
Decision Date	February 05, 1986
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—