ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
FDA 510(k) clearance K133067 · decided 2013-11-22
Clearance details
- K-number
- K133067
- Device name
- ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-27
- Decision date
- 2013-11-22
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- CDT
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Triglycerides (K150819) | Randox Laboratories Limited | 2015-08-06 |
| VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332) | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 |
| VANTERA CLINICAL ANALYZER (K113830) | Liposcience | 2012-08-30 |
| ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993) | Seppim S.A.S. | 2011-05-19 |
| OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804) | Olympus America, Inc. | 2007-03-23 |
| DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546) | Dade Behring, Inc. | 2005-01-18 |
| VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000) | Clinical Data, Inc. | 2004-03-10 |
| CARESIDE TRGLYCERIDE (K020488) | Careside, Inc. | 2002-04-15 |
| TGL FLEX REAGENT CARTRIDGE (K010871) | Dade Behring, Inc. | 2001-07-09 |
| WAKO L-TYPE TRIGLYCERIDE TEST (K993466) | Wako Chemicals USA, Inc. | 1999-11-09 |
| TRIGLYCERIDES, TG, OR TRIG (K971324) | Carolina Liquid Chemistries Corp. | 1997-06-20 |
| DMA TRIGLYCERIDES PROCEDURES (K971113) | Data Medical Associates, Inc. | 1997-05-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measu recall (Z-1270-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-08-29 |
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