Quikread(R) Whole Blood Triglyceride Test Kit
FDA 510(k) K897169 · Photec Diagnostics, Inc.
510(k) numberK897169
Submission
- Device name
- Quikread(R) Whole Blood Triglyceride Test Kit
- Applicant
- Photec Diagnostics, Inc.
Mahwah, NJ, US - Received
- December 28, 1989
- Decision date
- February 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1705
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150819 | TriglyceridesCDT · Traditional | Randox Laboratories Limited | 08/06/2015SE |
| K133067 | Advia Chemistry TRIGLYCERIDES_2 (TRIG_2) ReagentCDT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2013SE |
| K130332 | Vitros Chemistry Products Trig SlidesCDT · Special | Ortho-Clinical Diagnostics, Inc. | 05/31/2013SE |
| K113830 | Vantera Clinical AnalyzerCDT · Traditional | Liposcience | 08/30/2012SE |
| K102993 | Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLCDT · Traditional | Seppim S.A.S. | 05/19/2011SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | Olympus America, Inc. | 03/23/2007SE |
| K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleCDT · Special | Dade Behring, Inc. | 01/18/2005SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | Clinical Data, Inc. | 03/10/2004SE |
| K020488 | Careside TrglycerideCDT · Traditional | Careside, Inc. | 04/15/2002SE |
| K010871 | TGL Flex Reagent CartridgeCDT · Traditional | Dade Behring, Inc. | 07/09/2001SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | 12/12/1989SE |
| K894057 | Quikread Whole Blood Hdl-Cholesterol Test KitLBS · Traditional | 08/31/1989SE |
| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | 04/26/1989SE |
| K882307 | D-ChemJJE · Traditional | 08/02/1988SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | 08/28/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
Questions and answers
When was Quikread(R) Whole Blood Triglyceride Test Kit cleared by the FDA?
Quikread(R) Whole Blood Triglyceride Test Kit (K897169) received a 510(k) decision of Substantially Equivalent on February 23, 1990, 57 days after the submission was received.
What is the product code of K897169?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.