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510(k) K991880

LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY by Light Diagnostics — Product Code GQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1999
Date Received
June 2, 1999
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

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  • K971101 — HSV-2 ANTIGEN CONTROL SLIDES (July 1, 1997)
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  • 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)