510(k) K963827
- Device
- AXSYM FREE TRIIODOTHYRONINE (FREE T3)
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K963827
- Product code
- CDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-30
- Date received
- 1996-09-24
- Regulation
- 862.1710
- Classification name
- Radioimmunoassay, Total Triiodothyronine
- 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
- LAURA L GRANITZ
- Address
- 200 Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3017019647
- 3009335633
- 8010132
- 3005094123
- 3006198300
- 3009984016
- 3002800697
- 9680746
- 3017894300
- 2245285
- 3005333358
- 3003741796
- 2432235
- 3022178699
- 3012963943
- 3004434309
- 2250051
- 1832216
- 8023018
- 3002809144
- 3007118747
- 9612316
- 2020726
- 1222302
- 1036362
- 2517506
- 2122870
- 8031673
- 1827821
- 3011989923
- 2032682
- 3033967997
- 3002642396
- 3005984081
- 8020888
- 1219913
- 9610240
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000308930
- 3017379203
- 3002806944
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CDP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | 2000-10-05 |
| K991692 | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | 1999-06-18 |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | 1999-06-02 |
| K991252 | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | 1999-05-11 |
| K981824 | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | 1998-12-22 |
| K983434 | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | 1998-11-20 |
| K983439 | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | 1998-11-20 |
| K974027 | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| K974634 | IMMULITE FREE T3 | Diagnostic Products Corp. | 1998-01-02 |
| K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 |
| K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | 1997-06-16 |
| K971270 | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
| K965058 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | 1997-03-11 |
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 |
| K963127 | ELECSYS FT3 | Boehringer Mannheim Corp. | 1996-12-16 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases