Lipase Reagent System
FDA 510(k) K940457 · Medical Diagnostic Technologies, Inc.
510(k) numberK940457
Submission
- Device name
- Lipase Reagent System
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- February 1, 1994
- Decision date
- June 2, 1994
- 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 |
|---|---|---|---|
| K970124 | Lipase Reagent Set (Colipase Method)CET · Traditional | Teco Diagnostics | 03/06/1997SE |
| 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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|---|---|---|
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| K963106 | Chromolize PAI-1 KitGGP · Traditional | 11/18/1996SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | 06/05/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
Questions and answers
When was Lipase Reagent System cleared by the FDA?
Lipase Reagent System (K940457) received a 510(k) decision of Substantially Equivalent on June 2, 1994, 121 days after the submission was received.
What is the product code of K940457?
The FDA product code is CET – Olive Oil Emulsion (Turbidimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.