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FDA 510(k) Application Details - K944867
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
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510(K) Number
K944867
Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant
BIO-WHITTAKER, INC., A CAMBREX CO.
8830 BIGGS FORD RD.
WALKERSVILLE, MD 21793-8415 US
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LEIF E OLSEN
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Regulation Number
866.3780
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Classification Product Code
LGD
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More FDA Info for this Product Code
Date Received
09/27/1994
Decision Date
05/14/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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