Submission Details
| 510(k) Number | K941085 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 08, 1994 |
| Decision Date | May 17, 1994 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
LIPASE-PS ASSAY PROCEDURE NO. 805
May 1994
Decision
70d
Days
Class 1
Risk
About This 510(k) Submission
K941085 is an FDA 510(k) clearance for the LIPASE-PS ASSAY PROCEDURE NO. 805, a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I — General Controls, product code CHI), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 17, 1994, 70 days after receiving the submission on March 8, 1994. 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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