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510(k) K963353

LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) by Reckitt Benckiser, Inc. — Product Code LRJ

K963353 is an FDA 510(k) premarket notification submitted by Reckitt Benckiser, Inc. for the device "LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Reckitt Benckiser, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
August 26, 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 Reckitt Benckiser, Inc.

  • K173504 — K-Y Silicone (January 12, 2018)
  • K151884 — K-Y Marilyn Pleasure Gel (January 11, 2016)
  • K143532 — Durex Silicone (July 31, 2015)
  • K143511 — K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant (May 20, 2015)
  • K131643 — DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT (December 17, 2014)
  • K140193 — DUREX EMBRACE PERSONAL LUBRICANT (November 4, 2014)
  • K990703 — SPOROX II STERILIZING & DISINFECTING SOLUTION (March 30, 1999)
  • K970230 — SPOROX (October 29, 1997)

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