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510(k) K802102

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI by Calbiochem-Behring Corp. — Product Code GOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
September 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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