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510(k) K875101

VIROGEN CMV ANTIBODY TEST by Wampole Laboratories — Product Code LQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1988
Date Received
December 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Campylobacter Spp.
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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Other clearances for product code LQO

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