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Found 2 results

510(k) Data Aggregation

K Number

Device Name

VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT

Manufacturer

VANCOUVER BIOTECH LTD.

Date Cleared

2005-08-17

(156 days)

Product Code

MMI

Regulation Number

862.1215

Why did this record match?

Applicant Name (Manufacturer) :

VANCOUVER BIOTECH LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The VBL Serum Troponin I ELISA Test is intended for the quantitative determination of cardiac Troponin I in human serum. Measurement of Troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Device Description

Not Found

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K Number

Device Name

VBL SERUM TROPONIN I TEST, MODEL 1001

Manufacturer

VANCOUVER BIOTECH LTD.

Date Cleared

2003-03-31

(164 days)

Product Code

MMI

Regulation Number

862.1215

Why did this record match?

Applicant Name (Manufacturer) :

VANCOUVER BIOTECH LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Device Description

Not Found

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