The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for P.a.p. Test Kit, Ria-zyme.
| Device ID | K790040 |
| 510k Number | K790040 |
| Device Name: | P.A.P. TEST KIT, RIA-ZYME |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-08 |
| Decision Date | 1979-04-17 |