GHM · Test, Sickle Cell
Hematology · 21 CFR 864.7825 · Class 2
Overview
| Product Code | GHM |
|---|---|
| Device Name | Test, Sickle Cell |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023656 | SICKLE-CHEX SOLUBILITY KIT | Streck Laboratories, Inc. | Dec 30, 2002 | SESE |
| K013316 | SICKLE-CHEX | Streck Laboratories, Inc. | Nov 6, 2001 | SESE |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | Jul 1, 1996 | SESE |
| K911981 | HEMOCARD HEMOGLOBIN S | Isolab, Inc. | Oct 9, 1991 | SESE |
| K910430 | HEMOCARD-AS | Isolab, Inc. | Apr 15, 1991 | SESE |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | Pacific Hemostasis | Jul 31, 1987 | SESE |
| K860812 | SICKLE CELL REAGENT SET | Michclone Associates, Inc. | Apr 11, 1986 | SESE |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | Feb 24, 1986 | SESE |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | Pacific Hemostasis | Oct 31, 1985 | SESE |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | Isolab, Inc. | Sep 9, 1984 | SESE |
| K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | Michclone Associates, Inc. | Aug 9, 1984 | SESE |
| K842368 | SICKLE CELL REAGENT SET | Livonia Diagnostics, Inc. | Jul 20, 1984 | SESE |
| K841272 | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | Clinical Technology Corp. | Apr 13, 1984 | SESE |
| K841170 | SICKLE HB ASSAY | Isolab, Inc. | Apr 4, 1984 | SESE |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | Jul 28, 1983 | SESE |
| K820642 | SICKLE-CHECK | Panmed, Inc. | Apr 14, 1982 | SESE |
| K811828 | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | Aug 12, 1981 | SESE |
| K791971 | MONOJECT SICKLE CELL KIT | Sherwood Medical Co. | Nov 5, 1979 | SESE |
Top Applicants
- Isolab, Inc. — 4 clearances
- Anco Medical Reagents & Assoc. — 2 clearances
- Michclone Associates, Inc. — 2 clearances
- Pacific Hemostasis — 2 clearances
- Streck Laboratories, Inc. — 2 clearances
