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FDA 510(k) Application Details - K003247
Device Classification Name
Alkaline Picrate, Colorimetry, Creatinine
More FDA Info for this Device
510(K) Number
K003247
Device Name
Alkaline Picrate, Colorimetry, Creatinine
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI, FL 33166 US
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Contact
David Johnston
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
CGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2000
Decision Date
12/14/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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