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FDA 510(k) Application Details - K960850
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
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510(K) Number
K960850
Device Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
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
866.3120
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Classification Product Code
LJC
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Date Received
03/01/1996
Decision Date
02/04/1997
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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