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510(k) Data Aggregation

K Number

Device Name

ONTRAK TESTCUP 502, MODEL 3016641

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2000-06-29

(55 days)

Product Code

DKZ,DIO,DJJ,LAF,LDJ

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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