Product Code: GLK FDA class 2 21 CFR 864.8625

Control, Hematocrit

Hematology

The Hematocrit Control is a reference material used in hematology laboratories to verify and calibrate instruments that measure the proportion of red blood cells in whole blood. It is classified as FDA Class 2 (moderate risk), subject to general controls and special controls, and requires 510(k) clearance before marketing. The product code is GLK, regulated under 21 CFR 864.8625 in the Hematology specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: GLK
Device Class: FDA class 2
Regulation Number: 864.8625
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

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 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K121467	EUROTROL HEMATOCRIT CONTROL	May 10, 2013	Substantially Equivalent	Eurotrol B.V.
K021924	MEDICA EASYQC HEMATOCRIT CONTROL	Jun 24, 2002	Substantially Equivalent	Bionostics, Inc.
K020618	AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL	May 14, 2002	Substantially Equivalent	Aalto Scientific, Ltd.
K964452	HEMATACHEK	Feb 20, 1997	Substantially Equivalent	Richmond Diagnostics, Inc.
K961807	CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4	Jul 26, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K924926	MSI-HCT	Jan 07, 1993	Substantially Equivalent	Medical Specialties, Inc.
K893562	A.QC HCT LEVEL 1 AND 2	Jul 14, 1989	Substantially Equivalent	Johnson & Johnson Professionals, Inc.