The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Osmocel +.
| Device ID | K830188 |
| 510k Number | K830188 |
| Device Name: | OSMOCEL + |
| Classification | Diluent, Blood Cell |
| Applicant | HEMATOLOGY MARKETING ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-19 |
| Decision Date | 1983-03-01 |