FDA 510(k) Application Details - K951799

Device Classification Name Antiserum, Cf, Varicella-Zoster

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510(K) Number K951799
Device Name Antiserum, Cf, Varicella-Zoster
Applicant LIGHT DIAGNOSTICS
28835 SINGLE OAK DR.
TEMECULA, CA 92590 US
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Contact DALE DEMBROW
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Regulation Number 866.3900

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Classification Product Code GQX
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Date Received 04/19/1995
Decision Date 03/20/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K951799


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