The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Glyco-hemoglobin Diag. Test Kit.
Device ID | K801289 |
510k Number | K801289 |
Device Name: | LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | LEECO DIAGNOSTICS, 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 | 1980-05-30 |
Decision Date | 1980-06-30 |