BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
Device Facts
| Record ID | K925204 |
|---|---|
| Device Name | BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED |
| Applicant | Beckman Instruments, Inc. |
| Product Code | LCP · Hematology |
| Decision Date | Jan 12, 1993 |
| 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.
