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510(k) K152353

SeraQuest HSV Type 2 Specific IgG by Quest International, Inc. — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2016
Date Received
August 20, 2015
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

Other clearances by Quest International, Inc.

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  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)

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  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K993724 — HSV-2 ELISA IGG, MODEL EL0920G (February 1, 2000)