K823860 is an FDA 510(k) clearance for the NUCLIPASE (I125) PANCREATIC LIPASE. This device is classified as a Olive Oil Emulsion (turbidimetric), Lipase (Class I - General Controls, product code CET).
Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1983, 117 days after receiving the submission on December 22, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1465.
| 510(k) Number | K823860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1982 |
| Decision Date | April 18, 1983 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CET — Olive Oil Emulsion (turbidimetric), Lipase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1465 |