The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Compur* M1000 Hemoglobin & Erythrocyte.
| Device ID | K833708 |
| 510k Number | K833708 |
| Device Name: | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE |
| Classification | Red-cell Count By Photometry |
| Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKZ |
| CFR Regulation Number | 864.7100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-20 |
| Decision Date | 1984-01-04 |