The following data is part of a premarket notification filed by Biovation, Inc. with the FDA for Hematology Data Management Sys.
| Device ID | K821534 |
| 510k Number | K821534 |
| Device Name: | HEMATOLOGY DATA MANAGEMENT SYS |
| Classification | Lowry (colorimetric), Total Protein |
| Applicant | BIOVATION, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JGP |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-24 |
| Decision Date | 1982-06-10 |