510(k) K971141
- Device
- FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
- Applicant
- DADE CHEMISTRY SYSTEMS, INC.
- 510(k) number
- K971141
- Product code
- CEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-28
- Date received
- 1997-03-28
- Regulation
- 862.1695
- Classification name
- Radioimmunoassay, Free Thyroxine
- 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
- CATHY P CRAFT
- Address
- P.O. Box 6101, Glasgow Bldg. 500 Mailbox 514 Newark DE US 19714 19714
FDA Registration Numbers#
- 3005094123
- 3006198300
- 3002800697
- 1063851
- 3007349751
- 9680746
- 2245285
- 3005333358
- 2432235
- 3010324880
- 3022178699
- 3012963943
- 3004434309
- 2250051
- 3002809144
- 9612316
- 2020726
- 3009518015
- 1036362
- 2517506
- 2419955
- 3009092698
- 2122870
- 2032087
- 8031673
- 1827821
- 3011989923
- 3033967997
- 3002642396
- 3010825766
- 8020888
- 1219913
- 9610240
- 3005529799
- 3007111389
- 9610126
- 2029372
- 1319681
- 3014279513
- 3000308930
- 3002806944
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CEC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240273 | Access Free T4 | Beckman Coulter, Inc. | 2024-03-06 |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023-04-07 |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 |
| K181233 | Elecsys FT4 III | Roche Diagnostics | 2018-09-18 |
| K173122 | Abbott Architect Free T4 | Abbott Laboratories | 2017-10-27 |
| K152422 | FREND™ Free T4 Test System | Nanoentek USA, Inc. | 2016-02-17 |
| K132058 | VIDAS FT4 | Biomerieux S.A. | 2015-06-08 |
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | Roche Diagnostics | 2014-01-27 |
| K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | Siemens Healthcare Diagnostics, Inc. | 2013-09-13 |
| K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | 2013-04-04 |
| K123379 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | 2012-11-27 |
| K083373 | IMMULITE 2000 FREE T4 | Siemens Healthcare Diagnostics, Inc. | 2009-02-02 |
| K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | Siemens Healthcare Diagnostics | 2008-08-08 |
Legacy Summary#
summary
FDA Review#
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