K862674 is an FDA 510(k) clearance for the PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM. This device is classified as a Fluorometer (Class I - General Controls, product code JZT).
Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 1986, 32 days after receiving the submission on July 14, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4520.
| 510(k) Number | K862674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1986 |
| Decision Date | August 15, 1986 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZT — Fluorometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4520 |