Colorimeter, Photometer, Spectrophotometer For Clinical Use

Device Code: 464

Product Code(s): JJQ

Device Classification Information

Device Type ID464
Device NameColorimeter, Photometer, Spectrophotometer For Clinical Use
Regulation DescriptionColorimeter, Photometer, Or Spectrophotometer For Clinical Use.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.2300 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJJQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID464
DeviceColorimeter, Photometer, Spectrophotometer For Clinical Use
Product CodeJJQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionColorimeter, Photometer, Or Spectrophotometer For Clinical Use.
CFR Regulation Number862.2300 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
 9
Low Readings
 4
Calibration Problem
 4
Mechanical Problem
 3
Insufficient Information
 2
Low Test Results
 2
Device Operates Differently Than Expected
 2
Smoking
 2
Use Of Device Problem
 2
High Test Results
 1
Incorrect Software Programming Calculations
 1
Total Device Problems 32
Recalls
Manufacturer Recall Class Date Posted
1
QIAGEN Gaithersburg, Inc.
 II Jun-26-2015
2
Tecan US, Inc.
 II Aug-25-2016
TPLC Last Update: 2019-04-02 19:35:13
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