510(k) K080634
- Device
- ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K080634
- Product code
- DDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-08-11
- Date received
- 2008-03-06
- Regulation
- 866.5880
- Classification name
- Transferrin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN WEIST
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2084025
- 3005094123
- 3006198300
- 3003795116
- 1181121
- 9610806
- 2050012
- 3005333358
- 9610529
- 3012963943
- 2250051
- 1319808
- 3002809144
- 2182595
- 1000403749
- 2020726
- 2517506
- 2122870
- 1827821
- 3019906
- 3004493545
- 3016438761
- 3002642396
- 2050010
- 3010825766
- 3012471076
- 9610126
- 1319681
- 3000308930
- 3000148879
- 9614373
Source Documents#
Other 510(k) Records For Product Code DDG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240987 | Access sTfR | Beckman Coulter, Inc. | 2024-07-03 |
| K190495 | Transferrin | Biosystems S.A. | 2020-03-16 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018-11-05 |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2013-02-13 |
| K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | 2008-08-08 |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | Thermo Electron OY | 2007-08-08 |
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C | Good Biotech Corp. | 2007-04-23 |
| K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H | Dade Behring, Inc. | 2007-03-21 |
| K063322 | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H | Dade Behring, Inc. | 2007-01-24 |
| K053075 | N ANTISERA TO HUMAN TRANSFERRIN | Dade Behring, Inc. | 2006-03-16 |
| K042477 | VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN | Ortho-Clinical Diagnostics, Inc. | 2004-11-19 |
| K012371 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 |
| K012393 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | 2001-09-19 |
| K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL | The Binding Site, Ltd. | 2001-07-30 |
| K003064 | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 | Roche Diagnostics Corp. | 2001-05-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary