GHM — Test, Sickle Cell Class II
FDA product code GHM covers "Test, Sickle Cell", a Class II medical device regulated under 21 CFR 864.7825. Submissions are reviewed by the Hematology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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 |