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510(k) K801721

HSV BIO-BEAD TITRATION KIT by Litton Bionetics — Product Code GQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
July 23, 1980
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 Litton Bionetics

  • K840417 — EBNA ACIF KIT (December 27, 1984)
  • K834443 — ROTAVIRUS BIO-ENZABEAD SCREEN KIT (March 16, 1984)
  • K831343 — CMV RQ BIO-ENZABEAD KIT (August 8, 1983)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821804 — RUBELLA RQ BIO-ENZABEAD KIT (September 14, 1982)
  • K801722 — CMV BIO-BEAD TITRATION KIT (September 16, 1980)
  • K801720 — TOXO BIO-BEAD TITRATION KIT (September 16, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K791618 — TORCH BIO-BEAD SCREEN KIT (November 13, 1979)
  • K791614 — HSV BIO-BEAD SCREEN KIT (November 13, 1979)

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  • 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)