Submission Details
| 510(k) Number | K970905 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 1997 |
| Decision Date | June 04, 1997 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
Jun 1997
Decision
84d
Days
Class 1
Risk
About This 510(k) Submission
K970905 is an FDA 510(k) clearance for the SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT, 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 June 4, 1997, 84 days after receiving the submission on March 12, 1997. 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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