Submission Details
| 510(k) Number | K952180 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 1995 |
| Decision Date | August 17, 1995 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
Aug 1995
Decision
100d
Days
Class 1
Risk
About This 510(k) Submission
K952180 is an FDA 510(k) clearance for the CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 17, 1995, 100 days after receiving the submission on May 9, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.
Device Classification
| Product Code | CHI — Lipase-esterase, Enzymatic, Photometric, Lipase |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1465 |
Manufacturer
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