K893508 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI. This device is classified as a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II - Special Controls, product code JFH).
Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on August 4, 1989, 91 days after receiving the submission on May 5, 1989.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K893508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1989 |
| Decision Date | August 04, 1989 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | JFH — Acid Phosphatase (prostatic), Tartrate Inhibited |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |