The following data is part of a premarket notification filed by Eppendorf-brinkmann, Inc. with the FDA for Glycohemoglobin-skreen Test Kit.
| Device ID | K780819 |
| 510k Number | K780819 |
| Device Name: | GLYCOHEMOGLOBIN-SKREEN TEST KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | EPPENDORF-BRINKMANN, 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 | 1978-05-17 |
| Decision Date | 1978-11-07 |