The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Eltrachem Diatrac Glycosylated Hemoglob.
| Device ID | K834294 |
| 510k Number | K834294 |
| Device Name: | ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-01-24 |