GHM · Class II · 21 CFR 864.7825

FDA Product Code GHM: Test, Sickle Cell

Leading manufacturers include Isolab, Inc., Streck Laboratories, Inc. and Anco Medical Reagents & Assoc..

18
Total
18
Cleared
51d
Avg days
1979
Since

FDA 510(k) Cleared Test, Sickle Cell Devices (Product Code GHM)

18 devices
1–18 of 18
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656
Streck Laboratories, Inc.
Hematology · 61d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316
Streck Laboratories, Inc.
Hematology · 33d
Cleared Jul 01, 1996
SAS SICKLE CELL TEST
K960947
Sa Scientific, Inc.
Hematology · 115d
Cleared Oct 09, 1991
HEMOCARD HEMOGLOBIN S
K911981
Isolab, Inc.
Hematology · 159d
Cleared Apr 15, 1991
HEMOCARD-AS
K910430
Isolab, Inc.
Hematology · 73d
Cleared Jul 31, 1987
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
K872217
Pacific Hemostasis
Hematology · 52d
Cleared Feb 24, 1986
SICKLE CELL REAGENT SET
K860420
Sterling Diagnostics, Inc.
Hematology · 20d
Cleared Oct 31, 1985
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079
Pacific Hemostasis
Hematology · 24d
Cleared Sep 09, 1984
SICKLING HEMOGLOBIN CONTROLS, NORMAL
K842152
Isolab, Inc.
Hematology · 102d
Cleared Apr 04, 1984
SICKLE HB ASSAY
K841170
Isolab, Inc.
Hematology · 16d
Cleared Jul 28, 1983
SICKLE-HEME A/S CONTROLS & A/A CONTROL
K831871
Anco Medical Reagents & Assoc.
Chemistry · 45d
Cleared Aug 12, 1981
SICKLE CELL REAGENT SET
K811828
Anco Medical Reagents & Assoc.
Chemistry · 44d
Cleared Nov 05, 1979
MONOJECT SICKLE CELL KIT
K791971
Sherwood Medical Co.
Immunology · 34d

About Product Code GHM - Regulatory Context