510(k) K970539
- Device
- CHIRON DIAGNOSTICS ACS:180TU P
- Applicant
- CHIRON DIAGNOSTICS CORP.
- 510(k) number
- K970539
- Product code
- KHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-24
- Date received
- 1997-02-12
- Regulation
- 862.1715
- Classification name
- Radioassay, Triiodothyronine Uptake
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William J Pignato
- Address
- 63 N. St. Medfield MA US 02052 02052
FDA Registration Numbers#
- 3017019647
- 3006198300
- 3002800697
- 3003795116
- 1181121
- 2050012
- 3017894300
- 2245285
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 3008344661
- 3010939897
- 3002809144
- 9612316
- 2020726
- 2517506
- 2247288
- 8031673
- 3033967997
- 3002642396
- 2050010
- 3010825766
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000308930
Source Documents#
Other 510(k) Records For Product Code KHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 |
| K980088 | T-UPTAKE MICROPLATE EIA | Monobind | 1998-02-04 |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-11-27 |
| K961488 | ELECSYS T-UPTAKE ASSAY | Boehringer Mannheim Corp. | 1996-06-12 |
| K954807 | CEDIA T UPTAKE ASSAY | Boehringer Mannheim Corp. | 1995-12-21 |
| K951586 | T-UPTAKE EIA TEST | Diagnostic Reagents, Inc. | 1995-05-15 |
| K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1994-11-22 |
| K934312 | AXSYM(TM) T-UPTAKE | Abbott Laboratories | 1994-06-21 |
| K935816 | VIDAS T UPTAKE | Biomerieux Vitek, Inc. | 1994-03-22 |
| K926220 | T3 UPTAKE CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1993-11-17 |
| K931294 | IQ TUPTAKE ASSAY | Becton Dickinson Advanced Diagnostics | 1993-07-22 |
| K926443 | COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS | Roche Diagnostic Systems, Inc. | 1993-05-20 |
| K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-12-28 |
| K923676 | VISTA THYROXINE UPTAKE ASSAY | Syva Co. | 1992-10-09 |
| K913663 | AIA-PACK T-U | Tosoh Corp. | 1991-09-30 |
Legacy Summary#
summary
FDA Review#
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