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510(k) K033802

ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM by Zeus Scientific, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2004
Date Received
December 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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