Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

Device Code: 441

Product Code(s): JIQ

Device Classification Information

• Device Type ID: 441
• Device Name: Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
• Regulation Description: Urinary Protein Or Albumin (nonquantitative) 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: 862.1645 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JIQ
• 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: 441
• Device: Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
• Product Code: JIQ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Urinary Protein Or Albumin (nonquantitative) Test System.
• CFR Regulation Number: 862.1645 [🔎]

Premarket Reviews
Manufacturer	Decision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:34:42