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510(k) K951821

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY by Light Diagnostics — Product Code LIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1996
Date Received
April 20, 1995
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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Other clearances for product code LIN

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  • K905257 — OPUS CMV TEST SYSTEM (April 17, 1991)
  • K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (October 16, 1990)
  • K894002 — CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (August 10, 1989)