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510(k) K964535

VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT by S.C. Johnson & Son, Inc. — Product Code LRJ

K964535 is an FDA 510(k) premarket notification submitted by S.C. Johnson & Son, Inc. for the device "VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT". The FDA issued a decision of Substantially Equivalent on December 13, 1996. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. S.C. Johnson & Son, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1996
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type

Other clearances by S.C. Johnson & Son, Inc.

  • K964828 — VIREX II 128 GERMICIDAL CLEANER AND DEODORANT (December 19, 1996)
  • K964613 — VIREX II 256 GERMICIDAL CLEANER AND DEODORANT (December 13, 1996)
  • K964610 — TRIAD II DISINFECTANT CLEANER AND DEODORANT (December 13, 1996)
  • K821046 — COMPRES PORTABLE HEAT PADS (April 29, 1982)

Other clearances for product code LRJ

  • K992661 — CONTROL III ELITE (September 14, 1999)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K984485 — MICROSTAT 2 (January 13, 1999)
  • K983947 — AMERSE 2 (December 4, 1998)
  • K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (November 30, 1998)
  • K983585 — LOW PH PHENOLIC 256 (November 6, 1998)
  • K982985 — CITREX HOSPITAL SPRAY DISINFECTANT (November 2, 1998)
  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

FDA data resources