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510(k) K921616

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT by Incstar Corp. — Product Code LIN

Clearance Details

Decision
SN ()
Decision Date
August 11, 1992
Date Received
April 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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