Timer, General Laboratory

Device Code: 380

Product Code(s): JBS

Device Classification Information

Device Type ID380
Device NameTimer, General Laboratory
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 CodeJBS
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID380
DeviceTimer, General Laboratory
Product CodeJBS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
CFR Regulation Number862.2050 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
O-Two Medical Technologies, Inc.
II Jun-22-2017
TPLC Last Update: 2019-04-02 19:33:45

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