Paramax Lipase Reagent
FDA 510(k) K862440 · American Dade
510(k) numberK862440
Submission
- Device name
- Paramax Lipase Reagent
- Applicant
- American Dade
Santa Ana, CA, US - Received
- June 26, 1986
- Decision date
- August 4, 1986
- 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 |
| 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 |
More from Pointe Scientific, Inc.,
| 510(k) | Device | Decision |
|---|---|---|
| K873051 | Stratus(R) HFSH Fluorometric Enzyme ImmunoassayCGJ · Traditional | 10/20/1987SE |
| K873171 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 09/29/1987SE |
| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Paramax Lipase Reagent cleared by the FDA?
Paramax Lipase Reagent (K862440) received a 510(k) decision of Substantially Equivalent on August 4, 1986, 39 days after the submission was received.
What is the product code of K862440?
The FDA product code is CET – Olive Oil Emulsion (Turbidimetric), Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.