N-ASSAY TIA ANTITHROMBIN III TEST KIT
FDA 510(k) clearance K972257 · decided 1997-10-20
Clearance details
- K-number
- K972257
- Device name
- N-ASSAY TIA ANTITHROMBIN III TEST KIT
- Applicant
- Crestat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-17
- Decision date
- 1997-10-20
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- DDQ
- Device class
- 2
- Regulation number
- 864.7060
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Weston, CT, 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 |
|---|---|---|
| DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (K935307) | Baxter Diagnostics, Inc. | 1994-11-22 |
| TRACE TRANSFERRIN REAGENT (K932713) | Trace Scientific , Ltd. | 1993-09-30 |
| ANTITHROMBIN III RIA (K780012) | Ria Diagnostics | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.