GIG · Hemoglobinometer
Hematology · 21 CFR 864.7500 · Class 2
Overview
| Product Code | GIG |
|---|---|
| Device Name | Hemoglobinometer |
| Regulation | 21 CFR 864.7500 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973995 | RANDOX BILIRUBIN | Randox Laboratories, Ltd. | Dec 8, 1997 | SESE |
| K933836 | HBM HEMOGLOBINOMETER | Artel, Inc. | Mar 31, 1994 | SESE |
| K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | The Dow Chemical Co. | Jul 21, 1977 | SESE |
Top Applicants
- Artel, Inc. — 1 clearance
- Randox Laboratories, Ltd. — 1 clearance
- The Dow Chemical Co. — 1 clearance
