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510(k) K010588

ELECSYSCA 15-3 II ASSAY by Roche Diagnostics Corp. — Product Code MOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2001
Date Received
February 27, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Immunological, Antigen, Tumor
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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