KHQ — Radioassay, Triiodothyronine Uptake Class II
FDA product code KHQ covers "Radioassay, Triiodothyronine Uptake", a Class II medical device regulated under 21 CFR 862.1715. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHQ
- Device Class
- Class II
- Regulation Number
- 862.1715
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981375 | schiapparelli biosystems | ACE T UPTAKE REAGENT TU CALIBRATORS | June 10, 1998 |
| K980088 | monobind | T-UPTAKE MICROPLATE EIA | February 4, 1998 |
| K970539 | chiron diagnostics | CHIRON DIAGNOSTICS ACS:180TU P | March 24, 1997 |
| K964308 | johnson and johnson clinical diagnostics | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAK | November 27, 1996 |
| K961488 | boehringer mannheim | ELECSYS T-UPTAKE ASSAY | June 12, 1996 |
| K954807 | boehringer mannheim | CEDIA T UPTAKE ASSAY | December 21, 1995 |
| K951586 | diagnostic reagents | T-UPTAKE EIA TEST | May 15, 1995 |
| K933414 | baxter diagnostics | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | November 22, 1994 |
| K934312 | abbott laboratories | AXSYM(TM) T-UPTAKE | June 21, 1994 |
| K935816 | biomerieux vitek | VIDAS T UPTAKE | March 22, 1994 |
| K926220 | nichols institute diagnostics | T3 UPTAKE CHEMILUMINESCENCE ASSAY | November 17, 1993 |
| K931294 | becton dickinson advanced diagnostics | IQ TUPTAKE ASSAY | July 22, 1993 |
| K926443 | roche diagnostic systems | COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS | May 20, 1993 |
| K925257 | ciba corning diagnostics | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | December 28, 1992 |
| K923676 | syva | VISTA THYROXINE UPTAKE ASSAY | October 9, 1992 |
| K913663 | tosoh | AIA-PACK T-U | September 30, 1991 |
| K911912 | serono-baker diagnostics | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | September 18, 1991 |
| K911093 | ciba corning diagnostics | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | April 29, 1991 |
| K903396 | instrumentation laboratory | IL T UPTAKE ASSAY SYSTEM | October 12, 1990 |
| K902748 | advanced magnetics | SEROZYME FREE T3 IMMUNOASSAY | August 9, 1990 |