TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
FDA 510(k) clearance K961573 · decided 1996-08-19
Clearance details
- K-number
- K961573
- Device name
- TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
- Applicant
- Hybritech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-23
- Decision date
- 1996-08-19
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, 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 |
|---|---|---|
| TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY (P840019/S012) | Hybritech, Inc. | 1996-03-07 |
| STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY (P840019/S010) | Hybritech, Inc. | 1994-03-17 |
| TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY (P840019/S011) | Hybritech, Inc. | 1994-01-13 |
| TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (P840019/S009) | Hybritech, Inc. | 1990-04-17 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S008) | Hybritech, Inc. | 1989-12-13 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S007) | Hybritech, Inc. | 1989-09-06 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S006) | Hybritech, Inc. | 1987-04-30 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S005) | Hybritech, Inc. | 1986-11-05 |