The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hematrak Rbc Morphology.
| Device ID | K761207 |
| 510k Number | K761207 |
| Device Name: | HEMATRAK RBC MORPHOLOGY |
| Classification | Counter, Differential Cell |
| Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-07 |
| Decision Date | 1977-10-18 |