Product Code: JJR FDA class 1 21 CFR 862.1660

Electrolyte Controls (Assayed And Unassayed)

Clinical Chemistry

This device consists of assayed and unassayed electrolyte controls used in clinical chemistry laboratories to verify the accuracy and precision of electrolyte measurements such as sodium, potassium, chloride, and bicarbonate across analytical runs. It is classified as FDA Class 1, subject only to general controls with no premarket notification required. The product code is JJR, regulated under 21 CFR 862.1660, and falls within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JJR
Device Class: FDA class 1
Regulation Number: 862.1660
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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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 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K990971	EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816	Apr 27, 1999	Substantially Equivalent	Medica Corp.
K960592	ELECTROLYTE STANDARDS	May 13, 1996	Substantially Equivalent	Phoenix Diagnostics, Inc.
K955630	RNA MEDICAL HEMAT CONTROL	Mar 01, 1996	Substantially Equivalent	Bionostics, Inc.
K951435	AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL	May 02, 1995	Substantially Equivalent	Aalto Scientific, Ltd.
K943925	SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING	Oct 04, 1994	Substantially Equivalent	Quantimetrix Corp.
K934641	I-STAT CONTROL LEVELS 1,2,3	Dec 09, 1993	Substantially Equivalent	I-Stat Corp.
K912513	ELECTROLYTE CONTROL	Jul 19, 1991	Substantially Equivalent	Verichem Laboratories, Inc.
K902266	ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)	Jun 06, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K894576	CIBA CORNING CERTAIN LYTE	Oct 30, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K895582	QCLYTE PROTEIN-BASED ISE CONTROL	Oct 04, 1989	Substantially Equivalent	Baxter Healthcare Corp
K881773	DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET	Jun 10, 1988	Substantially Equivalent	Casco Standards
K881655	SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL	May 27, 1988	Substantially Equivalent	Biomedical Research & Development Laboratories, Inc.
K880710	PROTEIN BASE ISE CONTROL	Mar 24, 1988	Substantially Equivalent	Bionostics, Inc.
K863333	AVL ISE-TROL ELECTROLYTE CONTROL	Sep 29, 1986	Substantially Equivalent	Avl Scientific Corp.
K834505	HUMAN SERUM ELECTROLYTE CONTROL-LIQUID	Apr 13, 1984	Substantially Equivalent	Quantimetrix Corp.
K831389	STAT-TRAK LIQUID ELECTROLYTE CONTROL	Aug 10, 1983	Substantially Equivalent	United Diagnostics, Inc.
K792196	8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO	Nov 13, 1979	Substantially Equivalent	Photovolt Corp.