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FDA 510(k) Application Details - K053196
Device Classification Name
Test, Albumin Cobalt Binding
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510(K) Number
K053196
Device Name
Test, Albumin Cobalt Binding
Applicant
INVERNESS MEDICAL INNOVATIONS, INC.
51 SAWYER RD., SUITE 200
WALTHAM, MA 02453-3448 US
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Contact
JAMES M DELANEY
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Regulation Number
862.1215
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Classification Product Code
NJV
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More FDA Info for this Product Code
Date Received
11/16/2005
Decision Date
12/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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