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510(k) K950553

COLDCIDE-2 by Metrex Research Corp. — Product Code LRJ

K950553 is an FDA 510(k) premarket notification submitted by Metrex Research Corp. for the device "COLDCIDE-2". The FDA issued a decision of Substantially Equivalent on March 22, 1995. 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
March 22, 1995
Date Received
February 7, 1995
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.

  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K950516 — COLDCIDE-10 (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)
  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

FDA data resources