Submission Details
| 510(k) Number | K971505 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 1997 |
| Decision Date | June 11, 1997 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Jun 1997
Decision
47d
Days
Class 1
Risk
About This 510(k) Submission
K971505 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 11, 1997, 47 days after receiving the submission on April 25, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.
Device Classification
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |
Manufacturer
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