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FDA 510(k) Application Details - K981865
Device Classification Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
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510(K) Number
K981865
Device Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE RD.
INDIANAPOLIS, IN 46268 US
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Contact
MARGO ENRIGHT
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Regulation Number
862.1380
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Classification Product Code
JMK
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Date Received
05/28/1998
Decision Date
02/26/1999
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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