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FDA 510(k) Application Details - K962113
Device Classification Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
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510(K) Number
K962113
Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant
COLUMBIA BIOSCIENCE, INC.
182 THOMAS JOHSON DR.
SUITE 205
FREDERICK, MD 21702 US
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Contact
NORMAN JENKINS
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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
05/31/1996
Decision Date
11/05/1996
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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