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FDA 510(k) Application Details - K950148
Device Classification Name
Lambda, Antigen, Antiserum, Control
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510(K) Number
K950148
Device Name
Lambda, Antigen, Antiserum, Control
Applicant
BIOTEK SOLUTIONS, INC.
120-B CREMONA DR.
SANTA BARBARA, CA 93117 US
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Contact
DEBORAH D HINMAN
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Regulation Number
866.5550
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Classification Product Code
DEH
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More FDA Info for this Product Code
Date Received
01/17/1995
Decision Date
07/02/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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