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FDA 510(k) Application Details - K954687
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rubella
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510(K) Number
K954687
Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant
BIO-RAD LABORATORIES, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
CAROLE STAMP
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Regulation Number
866.3510
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Classification Product Code
LFX
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Date Received
10/11/1995
Decision Date
04/09/1996
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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