Lipase
FDA 510(k) K771903 · Simmler & Son, Inc.
510(k) numberK771903
Submission
- Device name
- Lipase
- Applicant
- Simmler & Son, Inc.
Mchenry, IL, US - Received
- October 7, 1977
- Decision date
- December 6, 1977
- 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 |
|---|---|---|
| K780817 | Globin-Terge · Traditional | 07/27/1978SE |
| K771906 | PhosphateCDT · Traditional | 12/06/1977SE |
| K771905 | Glycerol SubstrateCDT · Traditional | 12/06/1977SE |
| K771904 | Glycerol KinaseCDT · Traditional | 12/06/1977SE |
| K761086 | ReagentsJJC · Traditional | 01/12/1977SE |
| K760476 | Reagent, Lactate DehydrogenaseCFJ · Traditional | 11/01/1976SE |
| K760480 | Reagent, Total Protein DeterminationCEK · Traditional | 10/29/1976SE |
| K760479 | Reagent, Total Bilirubin DeterminationCIG · Traditional | 10/29/1976SE |
| K760478 | Reagent, Bun (Urea Nitrogen) Determ.CDW · Traditional | 10/29/1976SE |
| K760477 | REAGENTS-4 for Uric Acid DeterminationCDH · Traditional | 10/29/1976SE |
Questions and answers
When was Lipase cleared by the FDA?
Lipase (K771903) received a 510(k) decision of Substantially Equivalent on December 6, 1977, 60 days after the submission was received.
What is the product code of K771903?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.