The following data is part of a premarket notification filed by Nordiclab Intl. with the FDA for Nordiclab Prostatic Acid Phosphatase Ria.
| Device ID | K801988 |
| 510k Number | K801988 |
| Device Name: | NORDICLAB PROSTATIC ACID PHOSPHATASE RIA |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | NORDICLAB INTL. 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 | 1980-08-19 |
| Decision Date | 1980-09-26 |