ADENO VIRUS & CONTROLS
FDA 510(k) clearance K802929 · decided 1980-12-31
Clearance details
- K-number
- K802929
- Device name
- ADENO VIRUS & CONTROLS
- Applicant
- Orion Diagnostica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-19
- Decision date
- 1980-12-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GOD
- Device class
- 1
- Regulation number
- 866.3020
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RPS ADENO DETECTOR PLUS (K110722) | Rapid Pathogen Screening, Inc. | 2011-05-17 |
| RPS ADENO DETECTOR (K052092) | Rapid Pathogen Screening | 2005-11-22 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.