The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Autolyzer 800.
| Device ID | K841852 |
| 510k Number | K841852 |
| Device Name: | AUTOLYZER 800 |
| Classification | Counter, Differential Cell |
| Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-03 |
| Decision Date | 1984-09-05 |