JBB · Solubility, Hemoglobin, Abnormal
Hematology · 21 CFR 864.7825 · Class 2
Overview
| Product Code | JBB |
|---|---|
| Device Name | Solubility, Hemoglobin, Abnormal |
| Regulation | 21 CFR 864.7825 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932872 | SICKLE CELL TEST KIT | Histo-Med, Inc. | Aug 16, 1993 | SESE |
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Simmler, Inc. | Nov 29, 1989 | SESE |
Top Applicants
- Histo-Med, Inc. — 1 clearance
- Simmler, Inc. — 1 clearance
