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510(k) K954301

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) by Abbott Laboratories — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1997
Date Received
August 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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