K884596 is an FDA 510(k) clearance for the ABBOTT A-GENT LIPASE REAGENT. This device is classified as a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I - General Controls, product code CHI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 6, 1988, 33 days after receiving the submission on November 3, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1465.
| 510(k) Number | K884596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1988 |
| Decision Date | December 06, 1988 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHI — Lipase-esterase, Enzymatic, Photometric, Lipase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1465 |