K812865 is an FDA 510(k) clearance for the QUANTUMATIC DUAL-WAVELENGTH SPECTRO. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 10, 1981, 28 days after receiving the submission on October 13, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K812865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1981 |
| Decision Date | November 10, 1981 |
| Days to Decision | 28 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 |