Cleared Traditional

ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST

K873082 · Cambridge Bioscience Corp. · Microbiology
Feb 1988
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K873082 is an FDA 510(k) clearance for the ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST, a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Cambridge Bioscience Corp. (Worcester, US). The FDA issued a Cleared decision on February 24, 1988, 203 days after receiving the submission on August 5, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K873082 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1987
Decision Date February 24, 1988
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GOD — Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3020

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