T3 Uptake Kits
FDA 510(k) K822612 · Pcl-Ria, Inc.
510(k) numberK822612
Submission
- Device name
- T3 Uptake Kits
- Applicant
- Pcl-Ria, Inc.
Mchenry, IL, US - Received
- August 30, 1982
- Decision date
- September 30, 1982
- 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 |
|---|---|---|
| K830526 | B-Gcg System by RiaJHI · Traditional | 04/05/1983SE |
| K823014 | Digoxin KitDPB · Traditional | 11/01/1982SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | 11/01/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | 04/16/1982SE |
| K820358 | Follicle Stimulating Hormone KitCGJ · Traditional | 03/26/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | 03/25/1982SE |
| K812666 | Thyroxine (T4) 125ICDP · Traditional | 10/02/1981SE |
| K810867 | Follicle Stimulating Hormone (FSH)JIS · Traditional | 04/14/1981SE |
| K810852 | Follicle Stimulating Hormone AntiserumCGJ · Traditional | 04/08/1981SE |
| K810754 | Lutenizing HormonesCEP · Traditional | 03/31/1981SE |
Questions and answers
When was T3 Uptake Kits cleared by the FDA?
T3 Uptake Kits (K822612) received a 510(k) decision of Substantially Equivalent on September 30, 1982, 31 days after the submission was received.
What is the product code of K822612?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.