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FDA 510(k), K072836, CHOLESTRAK HDL CHOLESTEROL HOME TEST
FDA 510(k), K072836, CHOLESTRAK HDL CHOLESTEROL HOME TEST
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510(K) Number: K072836
Device Name: CHOLESTRAK HDL CHOLESTEROL HOME TEST
Manufacturer: Gary Lehnus
Device Classification Name: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation Number: LBS
Classification Product Code: KXA
Date Received: 10/03/2007
Decision Date: 12/27/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: CHOLESTRAK HDL CHOLESTEROL HOME TEST
Manufacturer: Gary Lehnus
Device Classification Name: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation Number: LBS
Classification Product Code: KXA
Date Received: 10/03/2007
Decision Date: 12/27/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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