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510(k) K883684

HERPES VIRUS CONTROL SLIDES by Val Tech Diagnostics, Inc. — Product Code GQN

K883684 is an FDA 510(k) premarket notification submitted by Val Tech Diagnostics, Inc. for the device "HERPES VIRUS CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on September 28, 1988. The device falls under product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Val Tech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1988
Date Received
August 29, 1988
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 Val Tech Diagnostics, Inc.

  • K883569 — HISTO-CHECK GRAM NEGATIVE SLIDES (October 6, 1988)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883232 — HISTONE REACTIVE ANA (September 7, 1988)
  • K883208 — HISTO-CHECK SLIDES (August 25, 1988)
  • K871395 — DUAL SUBSTRATE ANA (April 20, 1987)
  • K864668 — ANA TEST KIT (March 12, 1987)
  • K870732 — RAT LIVER NUCLEI TEST SYSTEM (March 10, 1987)

Other clearances for product code GQN

  • K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, M (October 24, 2007)
  • 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)
  • K971101 — HSV-2 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)

FDA data resources