K871307 is an FDA 510(k) clearance for the SYVA Q-SPEC PHOTOMETER. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 26, 1987, 55 days after receiving the submission on April 1, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K871307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1987 |
| Decision Date | May 26, 1987 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |