K925377 is an FDA 510(k) clearance for the IMX PAP. This device is classified as a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II - Special Controls, product code JFH).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 13, 1993, 82 days after receiving the submission on October 23, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K925377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1992 |
| Decision Date | January 13, 1993 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFH — Acid Phosphatase (prostatic), Tartrate Inhibited |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |