FDA 510(k) Application Details - K971534

Device Classification Name Drug Mixture Control Materials

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510(K) Number K971534
Device Name Drug Mixture Control Materials
Applicant BECKMAN
200 SOUTH KRAEMER BLVD.
W-337
BREA, CA 92621 US
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Contact FRANK MARTE
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 04/28/1997
Decision Date 05/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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