OraQuick Ebola Rapid Antigen Test
FDA 510(k) clearance DEN190025 · decided 2019-10-10
Clearance details
- K-number
- DEN190025
- Device name
- OraQuick Ebola Rapid Antigen Test
- Applicant
- OraSure Technologies, Inc.
- Decision
- Unknown
- Date received
- 2019-05-13
- Decision date
- 2019-10-10
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- QID
- Device class
- 2
- Regulation number
- 866.4002
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OraQuick HCV Rapid Antibody Test (P080027/S039) | OraSure Technologies, Inc. | 2021-04-20 |
| OraQuick HCV Rapid Antibody Test (P080027/S038) | OraSure Technologies, Inc. | 2021-02-25 |
| OraQuick HCV Rapid Antibody Test (P080027/S037) | OraSure Technologies, Inc. | 2020-10-16 |
| OraQuick HCV Rapid Antibody Test (P080027/S035) | OraSure Technologies, Inc. | 2019-09-11 |
| OraQuick HCV Rapid Antibody Test (P080027/S034) | OraSure Technologies, Inc. | 2018-12-06 |
| OraQuick HCV Rapid Antibody Test (P080027/S033) | OraSure Technologies, Inc. | 2018-04-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S032) | OraSure Technologies, Inc. | 2018-02-01 |
| OraQuick HCV Rapid Antibody Test (P080027/S031) | OraSure Technologies, Inc. | 2018-01-03 |