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FDA 510(k) Application Details - K953077
Device Classification Name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
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510(K) Number
K953077
Device Name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92821-6208 US
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SHERI L HALL
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Regulation Number
862.1795
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Classification Product Code
CDF
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More FDA Info for this Product Code
Date Received
06/30/1995
Decision Date
01/05/1996
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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