510(k) K043546
- Device
- DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K043546
- Product code
- CDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-01-18
- Date received
- 2004-12-23
- Regulation
- 862.1705
- Classification name
- Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STANLEY GORAK
- Address
- 500 Gbc Dr., M/S 514, P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 1063851
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 1832216
- 2029015
- 2517506
- 2247288
- 3007662974
- 3021010433
- 1827821
- 3011989923
- 3004493545
- 3016438761
- 3003593973
- 3002642396
- 2050010
- 3010825766
- 2085064
- 1616487
- 3014325803
- 9610126
- 1220972
- 1319681
- 3000308930
- 3006716639
- 3000148879
- 3006644620
Source Documents#
Other 510(k) Records For Product Code CDT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150819 | Triglycerides | Randox Laboratories Limited | 2015-08-06 |
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | Siemens Healthcare Diagnostics, Inc. | 2013-11-22 |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 |
| K113830 | VANTERA CLINICAL ANALYZER | Liposcience | 2012-08-30 |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | Seppim S.A.S. | 2011-05-19 |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Olympus America, Inc. | 2007-03-23 |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Clinical Data, Inc. | 2004-03-10 |
| K020488 | CARESIDE TRGLYCERIDE | Careside, Inc. | 2002-04-15 |
| K010871 | TGL FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-07-09 |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | 1999-11-09 |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Carolina Liquid Chemistries Corp. | 1997-06-20 |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | 1997-05-29 |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | 1997-03-28 |
| K963424 | OLYMPUS LIPASE REAGENT | Olympus America, Inc. | 1997-01-14 |
| K961281 | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 | Diagnostic Chemicals , Ltd. | 1996-08-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary