Free T3 Radioimmunoassay Kit
FDA 510(k) K862968 · Bioclinical Group
510(k) numberK862968
Submission
- Device name
- Free T3 Radioimmunoassay Kit
- Applicant
- Bioclinical Group
Cambridge, MA, US - Received
- August 6, 1986
- Decision date
- September 25, 1986
- 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K853837 | Lh/Fsh Radioimmunoassay KitCEP · Traditional | 10/16/1985SE |
| K832638 | Cortisol Radioimmunoassay KitCGR · Traditional | 09/12/1983SE |
| K823005 | Bio Mag Free T4 Radioimmunoassay KitCEC · Traditional | 12/15/1982SE |
| K823004 | Bio Mag Total T4 Radioimmunoassay KitCDX · Traditional | 11/05/1982SE |
| K822840 | Radioimmunoassay, Human ChorrionicJHI · Traditional | 10/27/1982SE |
| K822515 | B-Hcg Radioimmunoassay KitJHI · Traditional | 09/14/1982SE |
| K821241 | Free T4 Radioimmunoassay KitCEC · Traditional | 06/01/1982SE |
| K821101 | Total Radioimmunoassay KitCDX · Traditional | 05/05/1982SE |
Questions and answers
When was Free T3 Radioimmunoassay Kit cleared by the FDA?
Free T3 Radioimmunoassay Kit (K862968) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 50 days after the submission was received.
What is the product code of K862968?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.