ANTITHROMBIN III RIA
FDA 510(k) clearance K780012 · decided 1978-01-20
Clearance details
- K-number
- K780012
- Device name
- ANTITHROMBIN III RIA
- Applicant
- Ria Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1978-01-03
- Decision date
- 1978-01-20
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DDQ
- Device class
- 2
- Regulation number
- 864.7060
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ria Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| N-ASSAY TIA ANTITHROMBIN III TEST KIT (K972257) | Crestat Diagnostics, Inc. | 1997-10-20 |
| DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (K935307) | Baxter Diagnostics, Inc. | 1994-11-22 |
| TRACE TRANSFERRIN REAGENT (K932713) | Trace Scientific , Ltd. | 1993-09-30 |
Recalls involving this device
No recalls on record reference this clearance.