The following data is part of a premarket notification filed by General Diagnostics with the FDA for Control Tm 8.
| Device ID | K823794 |
| 510k Number | K823794 |
| Device Name: | CONTROL TM 8 |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-16 |
| Decision Date | 1983-01-14 |