Control, Hemoglobin, Abnormal

Device Code: 2350

Product Code(s): JCM

Device Classification Information

Device Type ID2350
Device NameControl, Hemoglobin, Abnormal
Regulation DescriptionAbnormal Hemoglobin Assay.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.7415 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJCM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2350
DeviceControl, Hemoglobin, Abnormal
Product CodeJCM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAbnormal Hemoglobin Assay.
CFR Regulation Number864.7415 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Tosoh Bioscience, Inc.
II Feb-17-2017
TPLC Last Update: 2019-04-02 20:10:15

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