LGL · Assay, Bart'S, Hemoglobin
Hematology · 21 CFR 864.7500 · Class 2
Overview
| Product Code | LGL |
|---|---|
| Device Name | Assay, Bart'S, Hemoglobin |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810976 | ALPHA-THAL SCREEN TM CONTROL | Isolab, Inc. | May 29, 1981 | SESE |
| K801771 | ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT | Isolab, Inc. | Jan 16, 1981 | SESE |
Top Applicants
- Isolab, Inc. — 2 clearances
