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510(k) K120846

TRANSPORT CULTURE MEDIUM DEVICE by Puritan Medical Products, LLC — Product Code LIO

K120846 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "TRANSPORT CULTURE MEDIUM DEVICE". The FDA issued a decision of Substantially Equivalent on June 8, 2012. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Puritan Medical Products, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2012
Date Received
March 20, 2012
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 Puritan Medical Products, LLC

  • K242820 — Puritan PurSafe Plus Collection and Transport System (May 27, 2025)
  • K162284 — Puritan Fecal Opti-Swab Collection and Transport System (November 4, 2016)
  • K160082 — Puritan Opti-Tranz Cary-Blair Collection and Transport System (July 29, 2016)
  • K142366 — Puritan OptiTranz Liquid Stuart Collection and Transport System (January 9, 2015)
  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • K113249 — TRANSPORT CULTURE MEDIUM DEVICE (March 1, 2012)

Other clearances for product code LIO

  • K222613 — ARX Liquid Amies Collection & Transport System (March 27, 2024)
  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • 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)

FDA data resources