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510(k) Data Aggregation

K Number

Device Name

ONTRAK TESTCUP-ER M2K

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

1999-04-13

(62 days)

Product Code

DKZ,DIS,DMY,JXM,KIO

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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