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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Contact SHERI L HALL
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Regulation Number 862.1795

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Classification Product Code CDF
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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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