Dac-Cel T3 Uptake
FDA 510(k) K810212 · Burroughs Wellcome Co.
510(k) numberK810212
Submission
- Device name
- Dac-Cel T3 Uptake
- Applicant
- Burroughs Wellcome Co.
Mchenry, IL, US - Received
- January 27, 1981
- Decision date
- February 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHQ – Radioassay, Triiodothyronine Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1715
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | Schiapparelli Biosystems, Inc. | 06/10/1998SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | Monobind | 02/04/1998SE |
| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | Chiron Diagnostics Corp. | 03/24/1997SE |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 11/27/1996SE |
| K961488 | Elecsys T-Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 06/12/1996SE |
| K954807 | Cedia T Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 12/21/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | Diagnostic Reagents, Inc. | 05/15/1995SE |
| K933414 | Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K934312 | Axsym(Tm) T-UptakeKHQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935816 | Vidas T UptakeKHQ · Traditional | Biomerieux Vitek, Inc. | 03/22/1994SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820069 | Wellcogen Group BGTZ · Traditional | 02/18/1982SE |
| K813508 | Sac-CelKTS · Traditional | 12/29/1981SE |
| K810215 | Dac-Cel HCGJHI · Traditional | 04/17/1981SE |
| K810214 | Dac-Cel DiagnatalJHI · Traditional | 03/06/1981SE |
| K810213 | Dac-Cel TSHJLW · Traditional | 02/10/1981SE |
| K791232 | Dac-Cel T3CDP · Traditional | 09/04/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | 09/04/1979SE |
| K781607 | Strep-TexGTZ · Traditional | 10/17/1978SE |
| K780874 | Thymune-TDDC · Traditional | 06/14/1978SE |
| K780873 | Thymune-MDDC · Traditional | 06/14/1978SE |
Questions and answers
When was Dac-Cel T3 Uptake cleared by the FDA?
Dac-Cel T3 Uptake (K810212) received a 510(k) decision of Substantially Equivalent on February 10, 1981, 14 days after the submission was received.
What is the product code of K810212?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.