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510(k) Data Aggregation

K Number

Device Name

ALPHA DX SYSTEM

Manufacturer

FIRST MEDICAL, INC.

Date Cleared

2001-03-13

(15 days)

Product Code

MMI,DDR,GKF,JHX,KHO

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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