REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
Device Facts
| Record ID | K893224 |
|---|---|
| Device Name | REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 |
| Applicant | Helena Laboratories |
| Product Code | LCP · Hematology |
| Decision Date | Jun 20, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
