Enzygnost Lipase Test
FDA 510(k) K844240 · Behring Diagnostics, Inc.
510(k) numberK844240
Submission
- Device name
- Enzygnost Lipase Test
- Applicant
- Behring Diagnostics, Inc.
La Jolla, CA, US - Received
- November 1, 1984
- Decision date
- February 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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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| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
Questions and answers
When was Enzygnost Lipase Test cleared by the FDA?
Enzygnost Lipase Test (K844240) received a 510(k) decision of Substantially Equivalent on February 12, 1985, 103 days after the submission was received.
What is the product code of K844240?
The FDA product code is CET – Olive Oil Emulsion (Turbidimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.