HEMOGLOBIN REAGENT
Device Facts
| Record ID | K821658 |
|---|---|
| Device Name | HEMOGLOBIN REAGENT |
| Applicant | Anco Medical Reagents & Assoc. |
| Product Code | KHG · Hematology |
| Decision Date | Jun 25, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7500 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Special Controls
*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
