The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Prostatic Acid Phosphatase Test.
| Device ID | K800693 |
| 510k Number | K800693 |
| Device Name: | STANBIO PROSTATIC ACID PHOSPHATASE TEST |
| Classification | Acid Phosphatase, Thymolphthale Inmonophosphate |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CKE |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-27 |
| Decision Date | 1980-04-16 |