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510(k) K831711

CMV IGM TEST by Gull Laboratories, Inc. — Product Code LKQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1983
Date Received
May 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

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  • K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)