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510(k) K982485

SERAQUEST CMV IGM by Quest Intl., Inc. — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
July 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
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  • K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (October 24, 2014)
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  • K040290 — DIASORIN LIAISON CMV IGM/IGG (June 1, 2005)
  • K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (December 16, 1999)
  • K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LI (January 11, 1999)