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FDA 510(k) Application Details - K972608
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
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510(K) Number
K972608
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN BT29 4QY IE
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Contact
P. ARMSTRONG
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Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
06/11/1997
Decision Date
08/04/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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