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510(k) K875361

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT by Disease Detection International, Inc. — Product Code LFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
December 31, 1987
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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  • K884249 — MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (April 10, 1989)
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Other clearances for product code LFZ

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  • K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (October 24, 2014)
  • K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (February 28, 2014)
  • K040290 — DIASORIN LIAISON CMV IGM/IGG (June 1, 2005)
  • K993952 — IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (December 16, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)