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510(k) K894002

CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY by Baxter Healthcare Corp — Product Code LIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1989
Date Received
June 5, 1989
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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  • K912592 — CMV-EA MAB TEST (December 4, 1991)
  • K905257 — OPUS CMV TEST SYSTEM (April 17, 1991)
  • K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (October 16, 1990)