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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2001-04-26

(121 days)

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Regulation Number

Type

Panel

Clinical Chemistry

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N/A

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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