Submission Details
| 510(k) Number | K864438 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 1986 |
| Decision Date | March 12, 1987 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
BECKMAN EPSILON(TM) LIPASE TEST KIT
Mar 1987
Decision
120d
Days
Class 1
Risk
About This 510(k) Submission
K864438 is an FDA 510(k) clearance for the BECKMAN EPSILON(TM) LIPASE TEST KIT, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 12, 1987, 120 days after receiving the submission on November 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.
Device Classification
| Product Code | CET — Olive Oil Emulsion (turbidimetric), Lipase |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1465 |
Manufacturer
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