510(k) K110722
- Device
- RPS ADENO DETECTOR PLUS
- Applicant
- RAPID PATHOGEN SCREENING, INC.
- 510(k) number
- K110722
- Product code
- GOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-17
- Date received
- 2011-03-15
- Regulation
- 866.3020
- Classification name
- Antigens, Cf (including Cf Control), Adenovirus 1-33
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Douglas Bueschel
- Address
- 7227 Delainey Ct. Sarasota FL US 34240 34240
FDA Registration Numbers#
- 3014150341
- 3024463179
- 1645225
- 3005984081
- 3031590640
- 2024674
- 3009746061
- 2032839
- 2245285
- 3033751096
- 3013296716
- 2182595
- 3011325031
- 2030538
- 3021090658
- 3005360469
- 1524213
- 3003917514
- 9615056
- 3002800697
Source Documents#
Other 510(k) Records For Product Code GOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052092 | RPS ADENO DETECTOR | Rapid Pathogen Screening | 2005-11-22 |
| K990630 | SAS ADENO TEST | Sa Scientific, Inc. | 1999-08-19 |
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | Immunoprobe, Inc. | 1997-12-22 |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | Cambridge Bioscience Corp. | 1988-07-08 |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 |
| K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Orion Diagnostica, Inc. | 1987-06-04 |
| K843649 | ADENOVIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K802929 | ADENO VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 |
Legacy Summary#
summary
FDA Review#
Decision Summary