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FDA 510(k) Application Details - K071433
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K071433
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
SPECIALTY MEDICAL SUPPLIES
940 CROSSROADS BLVD.
SEGUIN, TX 78155 US
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Contact
JOHN C GORMLEY
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2007
Decision Date
06/28/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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