Cleared Traditional

ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST

K873312 · Cambridge Bioscience Corp. · Microbiology
Feb 1988
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K873312 is an FDA 510(k) clearance for the ADENOCLONE(TM)-IFA, 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, 190 days after receiving the submission on August 18, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K873312 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1987
Decision Date February 24, 1988
Days to Decision 190 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

Similar Devices — GOD Antigens, Cf (including Cf Control), Adenovirus 1-33

All 10
RPS ADENO DETECTOR PLUS
K110722 · Rapid Pathogen Screening, Inc. · May 2011
RPS ADENO DETECTOR
K052092 · Rapid Pathogen Screening · Nov 2005
SAS ADENO TEST
K990630 · Sa Scientific, Inc. · Aug 1999
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc. · Dec 1997
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
K881894 · Cambridge Bioscience Corp. · Jul 1988
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
K873082 · Cambridge Bioscience Corp. · Feb 1988