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FDA 510(k) Application Details - K070757
Device Classification Name
Lowry (Colorimetric), Total Protein
More FDA Info for this Device
510(K) Number
K070757
Device Name
Lowry (Colorimetric), Total Protein
Applicant
POINTE SCIENTIFIC, INC.
5449 RESEARCH DRIVE
CANTON, MI 48188 US
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Contact
RON JAMISON
Other 510(k) Applications for this Contact
Regulation Number
862.1635
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Classification Product Code
JGP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2007
Decision Date
12/04/2007
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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