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510(k) K981023

KLEENASEPTIC by Metrex Research Corp. — Product Code LRJ

K981023 is an FDA 510(k) premarket notification submitted by Metrex Research Corp. for the device "KLEENASEPTIC". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Metrex Research Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1998
Date Received
March 19, 1998
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 Metrex Research Corp.

  • K950516 — COLDCIDE-10 (March 22, 1995)
  • K950553 — COLDCIDE-2 (March 22, 1995)
  • K931052 — METRICIDE 28 (December 6, 1994)
  • K931592 — METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE (December 6, 1994)
  • K930284 — METRICIDE (December 6, 1994)

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)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)
  • K961044 — NOVIGUARD QUICK DRY (July 3, 1997)

FDA data resources