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510(k) K162276

SeraQuest Herpes Type 1 Specific IgG by Quest International, Inc. — Product Code MXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2016
Date Received
August 12, 2016
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 Quest International, Inc.

  • K181514 — SeraQuest HSV Type 2 Specific IgG (June 13, 2019)
  • K152353 — SeraQuest HSV Type 2 Specific IgG (May 13, 2016)

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  • K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM (April 26, 2011)
  • K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS (May 8, 2009)
  • K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (November 18, 2008)