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510(k) K220924

Elecsys HSV-2 IgG (08948887160) by Roche Diagnostics — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
March 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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  • K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (November 10, 2008)
  • K061239 — EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (June 28, 2007)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
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