Nephelometer

Device Code: 3020

Product Code(s): JZW

Device Classification Information

Device Type ID3020
Device NameNephelometer
Regulation DescriptionImmunonephelometer Equipment.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.4540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJZW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3020
DeviceNephelometer
Product CodeJZW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionImmunonephelometer Equipment.
CFR Regulation Number866.4540 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
7
High Test Results
4
Low Test Results
3
Incorrect Or Inadequate Test Results
2
Mechanical Problem
1
Total Device Problems 17
TPLC Last Update: 2019-04-02 20:22:42

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