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510(k) K853137

CMV TEST by Gull Laboratories, Inc. — Product Code GQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1985
Date Received
July 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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