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510(k) Data Aggregation

K Number

Device Name

RAPID ELECTROPHORESIS ANALYZER

Manufacturer

HELENA LABORATORIES

Date Cleared

1996-10-25

(260 days)

Product Code

JHO,CEF,CFE,CIN,JBD,JHX,JJN,LCP

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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