The following data is part of a premarket notification filed by Bioware Products with the FDA for Alk-phos Biopak Gel.
| Device ID | K810144 |
| 510k Number | K810144 |
| Device Name: | ALK-PHOS BIOPAK GEL |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | BIOWARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-21 |
| Decision Date | 1981-02-02 |