MICRO-PLATE COTININE EIA
FDA 510(k) clearance K974534 · decided 1998-05-18
Clearance details
- K-number
- K974534
- Device name
- MICRO-PLATE COTININE EIA
- Applicant
- OraSure Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-02
- Decision date
- 1998-05-18
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- MKU
- Device class
- 1
- Regulation number
- 862.3220
- 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
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Psychemedics Microplate EIA for Cotinine in Hair (K192517) | Psychemedics Corporation | 2020-04-22 |
| LZI Cotinine II Enzyme Immunoassay (K192299) | Lin-Zhi International, Inc. | 2019-11-21 |
| STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (K062565) | Princeton BioMeditech Corp. | 2007-02-20 |
| COZART EIA COTININE URINE KIT (K021944) | Cozart Bioscience , Ltd. | 2003-05-14 |
| MICRO-PLATE COTININE EIA (K974234) | OraSure Technologies, Inc. | 1998-05-14 |
| AUTO-LYTE COTININE EIA (K972481) | OraSure Technologies, Inc. | 1997-10-21 |
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 |