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510(k) Data Aggregation

K Number

Device Name

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

Manufacturer

ROCHE DIAGNOSTIC SYSTEMS, INC.

Date Cleared

1996-02-09

(266 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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Device Name :

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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