GIQ · Hemoglobin S
Hematology · 21 CFR 864.7415 · Class 2
Overview
| Product Code | GIQ |
|---|---|
| Device Name | Hemoglobin S |
| Regulation | 21 CFR 864.7415 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
Classification Rationale
Class II (special controls). A control intended for use with an abnormal hemoglobin assay 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). A control intended for use with an abnormal hemoglobin assay 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 |
|---|---|---|---|---|
| K955719 | SICKLE-2000 | Medicus Technologies, Inc. | Aug 14, 1996 | SESE |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | Isolab, Inc. | Jan 20, 1995 | SESE |
| K874429 | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 | Hf Scientific, Inc. | Feb 4, 1988 | SESE |
Top Applicants
- Hf Scientific, Inc. — 1 clearance
- Isolab, Inc. — 1 clearance
- Medicus Technologies, Inc. — 1 clearance
