The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Prostatic Acid Phosphatase (pap) Rda Kit.
| Device ID | K811169 |
| 510k Number | K811169 |
| Device Name: | PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | AMERSHAM CORP. 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 | 1981-04-28 |
| Decision Date | 1981-05-15 |