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FDA 510(k) Application Details - K974762
Device Classification Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
More FDA Info for this Device
510(K) Number
K974762
Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant
AWARENESS TECHNOLOGY, INC.
1995 SW MARTIN HWY.
P.O. BOX 1679
PALM CITY, FL 34990 US
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Contact
MARY FREEMAN
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Regulation Number
862.2300
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Classification Product Code
JJQ
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More FDA Info for this Product Code
Date Received
12/19/1997
Decision Date
01/28/1998
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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