K952647 is an FDA 510(k) clearance for the IL TEST LIPASE. This device is classified as a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I - General Controls, product code CHI).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on July 20, 1995, 41 days after receiving the submission on June 9, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1465.
| 510(k) Number | K952647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1995 |
| Decision Date | July 20, 1995 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHI — Lipase-esterase, Enzymatic, Photometric, Lipase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1465 |