Lowry (colorimetric), Total Protein

Device Code: 400

Product Code(s): JGP

Device Classification Information

• Device Type ID: 400
• Device Name: Lowry (colorimetric), Total Protein
• Regulation Description: Total Protein Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1635 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JGP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 400
• Device: Lowry (colorimetric), Total Protein
• Product Code: JGP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Total Protein Test System.
• CFR Regulation Number: 862.1635 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Ortho-Clinical Diagnostics	II	Feb-09-2017

TPLC Last Update: 2019-04-02 19:34:04