The following data is part of a premarket notification filed by Biovation, Inc. with the FDA for Biovation Max Data Management System.
| Device ID | K853026 |
| 510k Number | K853026 |
| Device Name: | BIOVATION MAX DATA MANAGEMENT SYSTEM |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | BIOVATION, INC. 4050 LAKESIDE DR. San Pablo, CA 94806 -1936 |
| Contact | Edwin O Brown |
| Correspondent | Edwin O Brown BIOVATION, INC. 4050 LAKESIDE DR. San Pablo, CA 94806 -1936 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1985-08-02 |