AUTO-LYTE BARBITURATES EIA
FDA 510(k) clearance K982745 · decided 1998-11-18
Clearance details
- K-number
- K982745
- Device name
- AUTO-LYTE BARBITURATES EIA
- Applicant
- OraSure Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-06
- Decision date
- 1998-11-18
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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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 |