Lipase Reagent Set (Colipase Method)
FDA 510(k) K970124 · Teco Diagnostics
510(k) numberK970124
Submission
- Device name
- Lipase Reagent Set (Colipase Method)
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- January 14, 1997
- Decision date
- March 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CET – Olive Oil Emulsion (Turbidimetric), Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940457 | Lipase Reagent SystemCET · Traditional | Medical Diagnostic Technologies, Inc. | 06/02/1994SE |
| K915706 | Lipase Reagent SetCET · Traditional | Tech Intl. Co. | 02/18/1992SE |
| K901858 | Modified Labeling for Aca Lipase Analytical TestCET · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/12/1990SE |
| K893718 | Deltatest (R) Lipase IICET · Traditional | Electro-Nucleonics, Inc. | 09/28/1989SE |
| K885078 | Lipase SR Liquid Stable Reagent SetCET · Traditional | Medical Analysis Systems, Inc. | 03/13/1989SE |
| K864438 | Beckman Epsilon(Tm) Lipase Test KitCET · Traditional | Beckman Instruments, Inc. | 03/12/1987SE |
| K862440 | Paramax Lipase ReagentCET · Traditional | American Dade | 08/04/1986SE |
| K844240 | Enzygnost Lipase TestCET · Traditional | Behring Diagnostics, Inc. | 02/12/1985SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | Nuclear Diagnostics, Inc. | 04/18/1983SE |
| K812794 | LipaseCET · Traditional | Pointe Scientific, Inc., | 10/20/1981SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | 09/21/2017SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | 07/21/2017SE |
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | 06/01/2017SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | 07/22/2016SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | 03/07/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | 05/29/2014SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | 10/04/2011SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | 02/17/2011SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | 02/04/2011SE |
Questions and answers
When was Lipase Reagent Set (Colipase Method) cleared by the FDA?
Lipase Reagent Set (Colipase Method) (K970124) received a 510(k) decision of Substantially Equivalent on March 6, 1997, 51 days after the submission was received.
What is the product code of K970124?
The FDA product code is CET – Olive Oil Emulsion (Turbidimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.