K802579 is an FDA 510(k) clearance for the CYBREX TM FPQ FLUORESCENE POLARIZATION. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 12, 1980, 23 days after receiving the submission on October 20, 1980.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K802579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |