510(k) K812589
- Device
- ULTRA CHEM E-TRIG #65024
- Applicant
- HARLECO
- 510(k) number
- K812589
- Product code
- CDT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-24
- Date received
- 1981-09-11
- Regulation
- 862.1705
- Classification name
- Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
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 |
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE | Dade Behring, Inc. | 2005-01-18 |
| 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 |
Legacy Summary#
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FDA Review#
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