Product Code: JGP FDA class 2 21 CFR 862.1635

Lowry (Colorimetric), Total Protein

Clinical Chemistry

Lowry (Colorimetric) for Total Protein is a clinical chemistry test system using the Lowry colorimetric method to measure total protein concentration in serum or other biological fluids, used in nutritional assessment, liver function evaluation, and monitoring of various disease states. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JGP, regulated under 21 CFR 862.1635, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: JGP
Device Class: FDA class 2
Regulation Number: 862.1635
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 5 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K070757	MICROPROTEIN REAGENT SET	Dec 04, 2007	Substantially Equivalent	Pointe Scientific, Inc.,
K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	Feb 18, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K863112	PROTEINMETER	Dec 10, 1986	Substantially Equivalent	J. D. Assoc.
K821534	HEMATOLOGY DATA MANAGEMENT SYS	Jun 10, 1982	Substantially Equivalent	Biovation, Inc.
K792347	MICRO LOWRY PROTEINTEST	Dec 06, 1979	Substantially Equivalent	Panmed, Inc.