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510(k) K971101

HSV-2 ANTIGEN CONTROL SLIDES by Viral Antigens, Inc. — Product Code GQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1997
Date Received
March 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Viral Antigens, Inc.

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  • K964872 — VZV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K964870 — RSV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (December 4, 1990)

Other clearances for product code GQN

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  • K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080 (September 21, 2007)
  • K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (November 9, 1999)
  • K971662 — ELVIS HSV ID/TYPING TEST SYSTEM (November 18, 1997)
  • K964874 — HSV-1 ANTIGEN CONTROL SLIDES (July 1, 1997)
  • K960578 — ELVIS HSV GOLD (September 5, 1996)
  • K941924 — ELVIS HSV (May 1, 1995)
  • K911345 — HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (June 17, 1991)
  • K884761 — MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (December 5, 1988)
  • K883684 — HERPES VIRUS CONTROL SLIDES (September 28, 1988)