The following data is part of a premarket notification filed by Biological Corp. Of America with the FDA for Freeze Dried Ficin.
| Device ID | K813404 |
| 510k Number | K813404 |
| Device Name: | FREEZE DRIED FICIN |
| Classification | Solution, Stabilized Enzyme |
| Applicant | BIOLOGICAL CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1982-02-10 |