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510(k) K822344

ANTIMICROBIAL REMOVAL DEVICE (ARD) by Marion Laboratories, Inc. — Product Code LJF

K822344 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "ANTIMICROBIAL REMOVAL DEVICE (ARD)". The FDA issued a decision of Substantially Equivalent on August 25, 1982. The device falls under product code LJF (Device, Antimicrobial Drug Removal), a Class I device regulated under 21 CFR 866.2560. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1982
Date Received
August 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Antimicrobial Drug Removal
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by Marion Laboratories, Inc.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (May 27, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)

Other clearances for product code LJF

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K830372 — ARTIMICROBIAL REMOVAL DEVICE (April 8, 1983)
  • K830363 — BACTEC 170 TRYPTIC SOY BROTH W/RESINS (March 24, 1983)

FDA data resources