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FDA 510(k) Application Details - K050283
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K050283
Device Name
Enzymatic Method, Creatinine
Applicant
STANBIO LABORATORY
1261 NORTH MAIN ST.
BOERNE, TX 78006 US
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Contact
KIRK JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
02/07/2005
Decision Date
06/30/2005
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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