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510(k) Data Aggregation

K Number

Device Name

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

Manufacturer

NANO-DITECH CORPORATION

Date Cleared

2010-10-20

(83 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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