The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Hematology Quality Control Mixture.
| Device ID | K823930 |
| 510k Number | K823930 |
| Device Name: | HEMATOLOGY QUALITY CONTROL MIXTURE |
| Classification | Control, Platelet |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GJP |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-29 |
| Decision Date | 1983-02-01 |