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510(k) K984485

MICROSTAT 2 by Chemlink Laboratories, LLC — Product Code LRJ

K984485 is an FDA 510(k) premarket notification submitted by Chemlink Laboratories, LLC for the device "MICROSTAT 2". The FDA issued a decision of Substantially Equivalent on January 13, 1999. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
December 17, 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 for product code LRJ

  • K992661 — CONTROL III ELITE (September 14, 1999)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 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)
  • K961044 — NOVIGUARD QUICK DRY (July 3, 1997)

FDA data resources