Product code GHM— Hematology
SICKLE CELL REAGENT SET
- Classification name
- Test, Sickle Cell
- Device class
- Class 2
- Regulation
- 21 CFR 864.7825
- Advisory panel
- Hematology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code GHM
FDA has cleared devices under product code GHM between 1979 and 2002, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 2001
- 1996
- 1991
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1979
Top applicants under product code GHM
Recent clearances under product code GHM
- K023656 — SICKLE-CHEX SOLUBILITY KIT
- K013316 — SICKLE-CHEX
- K960947 — SAS SICKLE CELL TEST
- K911981 — HEMOCARD HEMOGLOBIN S
- K910430 — HEMOCARD-AS
- K872217 — THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
- K860812 — SICKLE CELL REAGENT SET
- K860420 — SICKLE CELL REAGENT SET
- K854079 — THROMBO SCREEN SICKLE CELL ASSAY SET
- K842152 — SICKLING HEMOGLOBIN CONTROLS, NORMAL
- K842955 — SICKLE-HEME A/S HETEROZYGOUS CONTROL
- K842368 — SICKLE CELL REAGENT SET
- K841272 — SICKLE-STAT HEMOGLOBIN S SCREEN KIT
- K841170 — SICKLE HB ASSAY
- K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL
- K820642 — SICKLE-CHECK
- K811828 — SICKLE CELL REAGENT SET
- K791971 — MONOJECT SICKLE CELL KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.