Synchron CX Systems Lipase (Lipa) Reagent
FDA 510(k) K970905 · Beckman Instruments, Inc.
510(k) numberK970905
Submission
- Device name
- Synchron CX Systems Lipase (Lipa) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- March 12, 1997
- Decision date
- June 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K897150 | Lipase Color [Toyo] Serum Lipase Test KitCHI · Traditional | Toyo Jozo Co., Ltd. | 02/26/1990SE |
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Questions and answers
When was Synchron CX Systems Lipase (Lipa) Reagent cleared by the FDA?
Synchron CX Systems Lipase (Lipa) Reagent (K970905) received a 510(k) decision of Substantially Equivalent on June 4, 1997, 84 days after the submission was received.
What is the product code of K970905?
The FDA product code is CHI – Lipase-Esterase, Enzymatic, Photometric, Lipase, a Class I (low risk) device regulated under 21 CFR 862.1465.