K980043 is an FDA 510(k) clearance for the CARESIDE CREATININE. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Exigent Diagnostics, Inc. (Culver City, US). The FDA issued a Cleared decision on March 30, 1998, 83 days after receiving the submission on January 6, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K980043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1998 |
| Decision Date | March 30, 1998 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |