Product Code: GLQ FDA class 2 21 CFR 864.8625

Mixture, Control, White-Cell And Red-Cell Indices

Hematology

The White-Cell and Red-Cell Indices Control Mixture is a quality control material used in hematology analyzers to verify the accuracy of measurements for red cell indices (such as MCV and MCH) and white cell counts. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is GLQ, regulated under 21 CFR 864.8625 in the Hematology specialty.

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FEI Numbers

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Basic Information

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

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 10 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K111211	CELL-DYN 22 PLUS CONTROL	Dec 22, 2011	Substantially Equivalent	Streck
K110718	CELL-CHEX WITH CPPD CRYSTALS	May 26, 2011	Substantially Equivalent	Streck
K101335	CELL-CHEX	Aug 23, 2010	Substantially Equivalent	Streck
K090137	STAK-CHEX PLUS RETICS	Mar 18, 2009	Substantially Equivalent	Streck
K000945	PARA 12 PLUS RETICS	Apr 18, 2000	Substantially Equivalent	Streck Laboratories, Inc.
K994388	XE CHECK	Jan 14, 2000	Substantially Equivalent	Streck Laboratories, Inc.
K992887	STAK-CHEX PLUS RETICS	Nov 22, 1999	Substantially Equivalent	Streck Laboratories, Inc.
K823794	CONTROL TM 8	Jan 14, 1983	Substantially Equivalent	General Diagnostics
K823587	UNI-CELL	Jan 05, 1983	Substantially Equivalent	Medical Specialties Laboratories
K823498	PARA 12	Dec 28, 1982	Substantially Equivalent	Streck Laboratories, Inc.