ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

Single (specified) Analyte Controls (assayed And Unassayed)

INVERNESS MEDICAL INNOVATIONS, INC.

The following data is part of a premarket notification filed by Inverness Medical Innovations, Inc. with the FDA for Ischemia Albumin Cobalt Binding Test (acb) Assay Verification Set.

Pre-market Notification Details

Device IDK060133
510k NumberK060133
Device Name:ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham,  MA  02453 -3448
ContactJames M Delaney
CorrespondentJames M Delaney
INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham,  MA  02453 -3448
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-18
Decision Date2006-02-16
Summary:summary

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