FDA 510(k) Applications for Medical Device Product Code "CDP"
(Radioimmunoassay, Total Triiodothyronine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983439 | ABBOTT LABORATORIES | ABBOTT ARCHITECT FREE T3 | 11/20/1998 |
| K983434 | ABBOTT LABORATORIES | ABBOTT ARCHITECT TOTAL T3 | 11/20/1998 |
| K963827 | ABBOTT LABORATORIES | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | 10/30/1996 |
| K963833 | ABBOTT LABORATORIES | IMX FREE TRIIODOTHYRONINE (FREE T3) | 10/30/1996 |
| K974027 | ALFA BIOTECH (UK) LTD. | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | 02/02/1998 |
| K962355 | BAYER CORP. | FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | 07/12/1996 |
| K973966 | BECKMAN INSTRUMENTS, INC. | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 10/31/1997 |
| K960913 | BIO-RAD LABORATORIES, INC. | ACCESS FREE T3 ASSAY | 03/29/1996 |
| K955435 | BIO-RAD LABORATORIES, INC. | ACCESS TOTAL T3 ASSAY (MODIFICATION) | 01/24/1996 |
| K991311 | BIOCHECK, INC. | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | 06/02/1999 |
| K960412 | BIOMERICA, INC. | T-3 MICROWELL EIA MODEL 7013 | 03/19/1996 |
| K981824 | BIOTECX LABORATORIES, INC. | OPTICOAT T3 EIA KIT | 12/22/1998 |
| K963127 | BOEHRINGER MANNHEIM CORP. | ELECSYS FT3 | 12/16/1996 |
| K962508 | BOEHRINGER MANNHEIM CORP. | ELECSYS T3 | 08/15/1996 |
| K962760 | BOEHRINGER MANNHEIM CORP. | ENZYMUN-TEST FT3 | 11/29/1996 |
| K991692 | CHIRON DIAGNOSTICS CORP. | CHIRON DIAGNOSTICS ACS: 180 FT3 | 06/18/1999 |
| K974634 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE FREE T3 | 01/02/1998 |
| K960550 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE T3 RIA | 03/06/1996 |
| K971270 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | DSL ACTIVE T3 EIA | 05/22/1997 |
| K970016 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | 01/30/1997 |
| K964310 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | 11/27/1996 |
| K971779 | MONOBIND | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | 06/16/1997 |
| K965058 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | 03/11/1997 |
| K001607 | REPROMEDIX CORP. | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | 10/05/2000 |
| K952557 | SIGMA DIAGNOSTICS, INC. | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS | 01/24/1996 |
| K991252 | TOSOH MEDICS, INC. | AIA-PACK FT3 ASSAY | 05/11/1999 |
| K963687 | TOSOH MEDICS, INC. | AIA-PACK FT3 ASSAY | 11/08/1996 |
| K961236 | UNITED BIOTECH, INC. | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | 05/30/1996 |
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