The following data is part of a premarket notification filed by Biovation, Inc. with the FDA for Differential Counting Board.
| Device ID | K915071 |
| 510k Number | K915071 |
| Device Name: | DIFFERENTIAL COUNTING BOARD |
| Classification | Counter, Differential Cell |
| Applicant | BIOVATION, INC. 875ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Edwin O.brown |
| Correspondent | Edwin O.brown BIOVATION, INC. 875ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-01-17 |