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510(k) K912592

CMV-EA MAB TEST by Gull Laboratories, Inc. — Product Code LIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
June 10, 1991
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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