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FDA 510(k) Application Details - K951550
Device Classification Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
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510(K) Number
K951550
Device Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Applicant
BIOTEST DIAGNOSTICS CORP.
66 FORD RD., SUITE 131
DENVILLE, NJ 07834 US
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Contact
PATRICIA E BONNESS
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Regulation Number
866.3175
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Classification Product Code
LIN
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Date Received
04/04/1995
Decision Date
01/30/1996
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
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