Enzlipase, Enzymatic Lipase Kit
FDA 510(k) K862312 · Nuclear Diagnostics, Inc.
510(k) numberK862312
Submission
- Device name
- Enzlipase, Enzymatic Lipase Kit
- Applicant
- Nuclear Diagnostics, Inc.
Northbrook, IL, US - Received
- June 18, 1986
- Decision date
- September 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHI – Lipase-Esterase, Enzymatic, Photometric, Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970905 | Synchron CX Systems Lipase (Lipa) ReagentCHI · Traditional | Beckman Instruments, Inc. | 06/04/1997SE |
| K961179 | Sentinel Lipase Liquid Model 17.401BCHI · Traditional | Equal Diagnostics, Inc. | 07/19/1996SE |
| K952180 | CX Lipase Reagent & Calibrator for Synchron CX SystemsCHI · Traditional | Beckman Instruments, Inc. | 08/17/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | Dupont Medical Products | 07/20/1995SE |
| K952647 | Il Test LipaseCHI · Traditional | Instrumentation Laboratory CO | 07/20/1995SE |
| K941085 | Lipase-Ps Assay Procedure No. 805CHI · Traditional | Sigma Diagnostics, Inc. | 05/17/1994SE |
| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | Nuclear Diagnostics, Inc. | 02/25/1994SE |
| K921249 | Wako Autokit Lipase-ColorCHI · Traditional | Wako Chemicals USA, Inc. | 07/21/1992SE |
| K920337 | Miles Lipase Sera-Pak MethodCHI · Traditional | Heraeus Kulzer, Inc. | 03/11/1992SE |
| K900827 | Colorimetric Chloride Product #4314125CHI · Traditional | American Research Products Co. | 05/02/1990SE |
More from American Research Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4KPS · Special | 06/13/2002SE |
| K002782 | Hermes HD Aq Acquisition Station and Hermes WorkstationLLZ · Traditional | 12/05/2000SE |
| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | 02/25/1994SE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad KitJNO · Traditional | 12/02/1993SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | 06/17/1987SE |
| K860472 | Nuclear Laser Alignment System for Cardic StressIWE · Traditional | 07/03/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | 06/13/1986SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | 06/25/1985SE |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep-JLW · Traditional | 12/29/1983SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | 04/18/1983SE |
Questions and answers
When was Enzlipase, Enzymatic Lipase Kit cleared by the FDA?
Enzlipase, Enzymatic Lipase Kit (K862312) received a 510(k) decision of Substantially Equivalent on September 26, 1986, 100 days after the submission was received.
What is the product code of K862312?
The FDA product code is CHI – Lipase-Esterase, Enzymatic, Photometric, Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.