GHM · Class II · 21 CFR 864.7825

FDA Product Code GHM: Test, Sickle Cell

Leading manufacturers include Isolab, Inc., Streck Laboratories, Inc. and Sherwood Medical Co..

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 Feb 24, 1986
SICKLE CELL REAGENT SET
K860420
Sterling Diagnostics, Inc.
Hematology · 20d
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 Nov 05, 1979
MONOJECT SICKLE CELL KIT
K791971
Sherwood Medical Co.
Immunology · 34d

About Product Code GHM - Regulatory Context