The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Prostate Specific Antigen Immunohistochemical Anti.
| Device ID | K893508 |
| 510k Number | K893508 |
| Device Name: | PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | J Norwood |
| Correspondent | J Norwood BAXTER HEALTHCARE CORP. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-05 |
| Decision Date | 1989-08-04 |