Shaker/stirrer

Device Code: 582

Product Code(s): JRQ

Device Classification Information

Device Type ID582
Device NameShaker/stirrer
Regulation DescriptionGeneral Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical 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 Number862.2050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJRQ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID582
DeviceShaker/stirrer
Product CodeJRQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
CFR Regulation Number862.2050 [🔎]
TPLC Last Update: 2019-04-02 19:36:51

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