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510(k) K021486

HERPESELECT 2 ELISA IGG, MODEL ELO920G by Focus Technologies, Inc. — Product Code MXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2002
Date Received
May 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Focus Technologies, Inc.

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  • K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
  • K021429 — HERPESELECT 1 ELISA IGG, MODEL EL0910G (July 29, 2002)

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