The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Elt-8/ds Hematology Analyzer & Lysrig.
| Device ID | K831271 |
| 510k Number | K831271 |
| Device Name: | ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG |
| Classification | Counter, Differential Cell |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-19 |
| Decision Date | 1983-07-26 |