Product Code: GHM FDA class 2 21 CFR 864.7825

Test, Sickle Cell

Hematology

The Test, Sickle Cell (product code GHM) is a hematology assay used to detect the presence of hemoglobin S in red blood cells, enabling the screening and diagnosis of sickle cell trait and sickle cell disease. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7825 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GHM
Device Class: FDA class 2
Regulation Number: 864.7825
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K023656	SICKLE-CHEX SOLUBILITY KIT	Dec 30, 2002	Substantially Equivalent	Streck Laboratories, Inc.
K013316	SICKLE-CHEX	Nov 06, 2001	Substantially Equivalent	Streck Laboratories, Inc.
K960947	SAS SICKLE CELL TEST	Jul 01, 1996	Substantially Equivalent	Sa Scientific, Inc.
K911981	HEMOCARD HEMOGLOBIN S	Oct 09, 1991	Substantially Equivalent	Isolab, Inc.
K910430	HEMOCARD-AS	Apr 15, 1991	Substantially Equivalent	Isolab, Inc.
K872217	THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT	Jul 31, 1987	Substantially Equivalent	Pacific Hemostasis
K860812	SICKLE CELL REAGENT SET	Apr 11, 1986	Substantially Equivalent	Michclone Associates, Inc.
K860420	SICKLE CELL REAGENT SET	Feb 24, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K854079	THROMBO SCREEN SICKLE CELL ASSAY SET	Oct 31, 1985	Substantially Equivalent	Pacific Hemostasis
K842152	SICKLING HEMOGLOBIN CONTROLS, NORMAL	Sep 09, 1984	Substantially Equivalent	Isolab, Inc.
K842955	SICKLE-HEME A/S HETEROZYGOUS CONTROL	Aug 09, 1984	Substantially Equivalent	Michclone Associates, Inc.
K842368	SICKLE CELL REAGENT SET	Jul 20, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K841272	SICKLE-STAT HEMOGLOBIN S SCREEN KIT	Apr 13, 1984	Substantially Equivalent	Clinical Technology Corp.
K841170	SICKLE HB ASSAY	Apr 04, 1984	Substantially Equivalent	Isolab, Inc.
K831871	SICKLE-HEME A/S CONTROLS & A/A CONTROL	Jul 28, 1983	Substantially Equivalent	Anco Medical Reagents & Assoc.
K820642	SICKLE-CHECK	Apr 14, 1982	Substantially Equivalent	Panmed, Inc.
K811828	SICKLE CELL REAGENT SET	Aug 12, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K791971	MONOJECT SICKLE CELL KIT	Nov 05, 1979	Substantially Equivalent	Sherwood Medical Co.