Panels › Microbiology › Product code GOD · Class 1
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Regulation 866.3020
0510(k)s in 12 months (11 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Cambridge Bioscience Corp. | 3 | 0 |
| Orion Diagnostica, Inc. | 2 | 0 |
| Rapid Pathogen Screening | 2 | 0 |
| Cell Marque Corporation | 0 | 1 |
| Immunoprobe, Inc. | 1 | 0 |
| Institute Virion , Ltd. | 1 | 0 |
| Microscan Div. Baxter Healthcare Corp. | 1 | 0 |
| Sa Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2011 | K110722 | RPS ADENO DETECTOR PLUS Rapid Pathogen Screening, Inc. | GOD |
| Nov 22, 2005 | K052092 | RPS ADENO DETECTOR Rapid Pathogen Screening | GOD |
| Aug 19, 1999 | K990630 | SAS ADENO TEST Sa Scientific, Inc. | GOD |
| Dec 22, 1997 | K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM Immunoprobe, Inc. | GOD |
| Jul 8, 1988 | K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) Cambridge Bioscience Corp. | GOD |
| Feb 24, 1988 | K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST Cambridge Bioscience Corp. | GOD |
| Feb 24, 1988 | K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST Cambridge Bioscience Corp. | GOD |
| Jun 26, 1987 | K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL Microscan Div. Baxter Healthcare Corp. | GOD |
| Jun 4, 1987 | K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | GOD |
| Sep 26, 1985 | K843649 | ADENOVIRUS Institute Virion , Ltd. | GOD |
| Dec 31, 1980 | K802929 | ADENO VIRUS & CONTROLS Orion Diagnostica, Inc. | GOD |
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