Atlas FDA

GOD

11 FDA 510(k) clearances · Product code

174 daysmedian time to decision
203 days90th percentile
11clearances measured

FDA profile

Official device name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Device class
Class I (low risk)
Regulation
21 CFR 866.3020
Medical specialty
Microbiology
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RecordFirmDate
RPS ADENO DETECTOR PLUS (K110722)Rapid Pathogen Screening, Inc.2011-05-17
RPS ADENO DETECTOR (K052092)Rapid Pathogen Screening2005-11-22
SAS ADENO TEST (K990630)Sa Scientific, Inc.1999-08-19
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (K972406)Immunoprobe, Inc.1997-12-22
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (K881894)Cambridge Bioscience Corp.1988-07-08
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (K873082)Cambridge Bioscience Corp.1988-02-24
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (K873312)Cambridge Bioscience Corp.1988-02-24
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (K871229)Microscan Div. Baxter Healthcare Corp.1987-06-26
ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)Orion Diagnostica, Inc.1987-06-04
ADENOVIRUS (K843649)Institute Virion , Ltd.1985-09-26
ADENO VIRUS & CONTROLS (K802929)Orion Diagnostica, Inc.1980-12-31

Track GOD automatically

Every clearance here is in the API, with alerts when new ones post.