The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Hematall-c Plus Hematology Controls.
| Device ID | K820731 |
| 510k Number | K820731 |
| Device Name: | HEMATALL-C PLUS HEMATOLOGY CONTROLS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-17 |
| Decision Date | 1982-05-12 |