GHM — Test, Sickle Cell Class II
FDA Device Classification
Classification Details
- Product Code
- GHM
- Device Class
- Class II
- Regulation Number
- 864.7825
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K023656 | streck laboratories | SICKLE-CHEX SOLUBILITY KIT | December 30, 2002 |
| K013316 | streck laboratories | SICKLE-CHEX | November 6, 2001 |
| K960947 | sa scientific | SAS SICKLE CELL TEST | July 1, 1996 |
| K911981 | isolab | HEMOCARD HEMOGLOBIN S | October 9, 1991 |
| K910430 | isolab | HEMOCARD-AS | April 15, 1991 |
| K872217 | pacific hemostasis | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | July 31, 1987 |
| K860812 | michclone associates | SICKLE CELL REAGENT SET | April 11, 1986 |
| K860420 | sterling diagnostics | SICKLE CELL REAGENT SET | February 24, 1986 |
| K854079 | pacific hemostasis | THROMBO SCREEN SICKLE CELL ASSAY SET | October 31, 1985 |
| K842152 | isolab | SICKLING HEMOGLOBIN CONTROLS, NORMAL | September 9, 1984 |
| K842955 | michclone associates | SICKLE-HEME A/S HETEROZYGOUS CONTROL | August 9, 1984 |
| K842368 | livonia diagnostics | SICKLE CELL REAGENT SET | July 20, 1984 |
| K841272 | clinical technology | SICKLE-STAT HEMOGLOBIN S SCREEN KIT | April 13, 1984 |
| K841170 | isolab | SICKLE HB ASSAY | April 4, 1984 |
| K831871 | anco medical reagents and assoc | SICKLE-HEME A/S CONTROLS & A/A CONTROL | July 28, 1983 |
| K820642 | panmed | SICKLE-CHECK | April 14, 1982 |
| K811828 | anco medical reagents and assoc | SICKLE CELL REAGENT SET | August 12, 1981 |
| K791971 | sherwood medical | MONOJECT SICKLE CELL KIT | November 5, 1979 |