510(k) K060628
- Device
- DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K060628
- Product code
- CIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-06
- Date received
- 2006-03-09
- Regulation
- 862.1110
- Classification name
- Diazo Colorimetry, Bilirubin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE M PLUMMER
- Address
- Glasgow Business Community Bldg. 500, Ms 514 P.O.Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 2431530
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 1217183
- 1832216
- 1649661
- 8040374
- 3002809144
- 1181055
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 3002807968
- 2939693
- 3016438761
- 3003593973
- 3002642396
- 2050010
- 3005146313
- 3010825766
- 3037000637
- 1217058
- 3013513377
- 2085064
- 1616487
- 9610126
- 1220972
- 1319681
- 1219029
- 3021841051
- 3000308930
- 3006716639
- 3000148879
Source Documents#
Other 510(k) Records For Product Code CIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Elitechgroup | 2017-07-11 |
| K150510 | Total Bilirubin | Abbott Laboratories | 2015-04-02 |
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 | Roche Diagnostics | 2013-07-17 |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Medica Corp. | 2013-03-01 |
| K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | Roche Diagnostics | 2013-02-28 |
| K121985 | ARCHITECT TOTAL BILIRUBIN | Abbott Laboratories | 2013-02-01 |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | Elitechgroup | 2011-10-07 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | 2011-09-01 |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | Instrumentation Laboratory CO | 2010-06-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary