K813146 is an FDA 510(k) clearance for the SYVA ADVANCE TM FLUOROMETER. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981, 21 days after receiving the submission on November 6, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K813146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1981 |
| Decision Date | November 27, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |