K802886 is an FDA 510(k) clearance for the NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-. This device is classified as a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II - Special Controls, product code JFH).
Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 72 days after receiving the submission on November 17, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K802886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1980 |
| Decision Date | January 28, 1981 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFH — Acid Phosphatase (prostatic), Tartrate Inhibited |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |