FDA 510(k) Application Details - K955448

Device Classification Name Radioimmunoassay, Lsd (125-I)

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510(K) Number K955448
Device Name Radioimmunoassay, Lsd (125-I)
Applicant BEHRING DIAGNOSTICS, INC.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE, CA 95161-9013 US
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Contact PAUL L ROGERS, JR.
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Regulation Number 862.3580

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Classification Product Code DLB
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Date Received 11/29/1995
Decision Date 02/23/1996
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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