EMC-M-180, T3 Uptake - 100 Tubes
FDA 510(k) K800188 · Endocrine-Metabolic Center
510(k) numberK800188
Submission
- Device name
- EMC-M-180, T3 Uptake - 100 Tubes
- Applicant
- Endocrine-Metabolic Center
Mchenry, IL, US - Received
- January 29, 1980
- Decision date
- February 13, 1980
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K821131 | Radioimmunoassay Parathyroid Hormone MidCEW · Traditional | 06/02/1982SE |
| K811993 | Radioimmunoassay, Follicle StimulatingCGJ · Traditional | 08/03/1981SE |
| K811994 | Radioimmunoassay Luteinizing HormoneCEP · Traditional | 07/27/1981SE |
| K810948 | Radioimmunoassay Thyroid Stim. Horm. KitJLW · Traditional | 04/17/1981SE |
| K810351 | Radioimmunoassay, Total TriiodothronieCDP · Traditional | 02/23/1981SE |
| K800187 | EMC-M-175, Thyroxine - 100 TubesCDX · Traditional | 02/13/1980SE |
| K790602 | Ria, DIGNXIN-125-IDPB · Traditional | 07/30/1979SE |
| K790630 | Ria, Insulin, Double AntibodyCFP · Traditional | 07/24/1979SE |
Questions and answers
When was EMC-M-180, T3 Uptake - 100 Tubes cleared by the FDA?
EMC-M-180, T3 Uptake - 100 Tubes (K800188) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 15 days after the submission was received.
What is the product code of K800188?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.