The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Unitized Hematology Set 65132/93.
| Device ID | K840477 |
| 510k Number | K840477 |
| Device Name: | UNITIZED HEMATOLOGY SET 65132/93 |
| Classification | Diluent, Blood Cell |
| Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-03 |
| Decision Date | 1984-03-05 |