Home / 510(k) Clearances / K222613

510(k) K222613

ARX Liquid Amies Collection & Transport System by Arx Sciences, Inc. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2024
Date Received
August 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Arx Sciences, Inc.

  • K231843 — ARX Viral Transport Media Collection and Transport System (March 19, 2024)

Other clearances for product code LIO

  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
  • K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION (January 25, 2011)
  • K082472 — VIROCULT, MODEL MW950 (December 30, 2008)
  • K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL (July 30, 2007)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)
  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)
  • K964144 — PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - (November 27, 1996)