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FDA 510(k) Application Details - K962558
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
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510(K) Number
K962558
Device Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Applicant
ARMKEL, LLC.
1306F BAILES LN.
FREDERICK, MD 21701 US
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Contact
WILLIAM L BOTELER
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Regulation Number
866.3120
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Classification Product Code
LJC
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More FDA Info for this Product Code
Date Received
07/01/1996
Decision Date
02/24/1997
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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