K871550 is an FDA 510(k) clearance for the PFI-20 POLARIZING FLUORIMETER. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on July 1, 1987, 70 days after receiving the submission on April 22, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K871550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1987 |
| Decision Date | July 01, 1987 |
| Days to Decision | 70 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 |