Antithrombin III Ria
FDA 510(k) K780012 · Ria Diagnostics
510(k) numberK780012
Submission
- Device name
- Antithrombin III Ria
- Applicant
- Ria Diagnostics
Mchenry, IL, US - Received
- January 3, 1978
- Decision date
- January 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDQ – Antigen, Antiserum, Control, Antithrombin Iii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
Other 510(k)s with product code DDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | Crestat Diagnostics, Inc. | 10/20/1997SE |
| K935307 | Dade(R) Thrombin-Antithrombin (Tat) Complex ElisaDDQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | Trace Scientific , Ltd. | 09/30/1993SE |
More from Trace Scientific , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K855033 | T-3 Uptake/RiassayKHQ · Traditional | 01/24/1986SE |
| K854798 | T-4 RiassayCDX · Traditional | 01/15/1986SE |
| K852537 | T-3 RiassayCDP · Traditional | 08/12/1985SE |
| K810296 | Digoxin Ria AssayDON · Traditional | 02/19/1981SE |
| K801691 | TSH RiassayJLW · Traditional | 08/27/1980SE |
| K792062 | Theophylline RiassayLCA · Traditional | 02/25/1980SE |
Questions and answers
When was Antithrombin III Ria cleared by the FDA?
Antithrombin III Ria (K780012) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 17 days after the submission was received.
What is the product code of K780012?
The FDA product code is DDQ – Antigen, Antiserum, Control, Antithrombin Iii, a Class II (moderate risk) device regulated under 21 CFR 864.7060.