Atomic Absorption, Calcium

Device Code: 385

Product Code(s): JFN

Device Classification Information

Device Type ID385
Device NameAtomic Absorption, Calcium
Regulation DescriptionCalcium Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1145 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJFN
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 ID385
DeviceAtomic Absorption, Calcium
Product CodeJFN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCalcium Test System.
CFR Regulation Number862.1145 [🔎]
TPLC Last Update: 2019-04-02 19:33:49

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