The following data is part of a premarket notification filed by Immunogenetics with the FDA for Control Diagnostics Platelet Control.
| Device ID | K821851 |
| 510k Number | K821851 |
| Device Name: | CONTROL DIAGNOSTICS PLATELET CONTROL |
| Classification | Calibrator For Platelet Counting |
| Applicant | IMMUNOGENETICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRY |
| CFR Regulation Number | 864.8175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-23 |
| Decision Date | 1982-09-02 |