The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Abnormal Glycosylated Hemoglobin Control.
| Device ID | K811000 |
| 510k Number | K811000 |
| Device Name: | ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1981-04-13 |
| Decision Date | 1981-05-08 |