The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho*pap-ia Endogenous Enzyme Immuno.
| Device ID | K831670 |
| 510k Number | K831670 |
| Device Name: | ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-08-24 |