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510(k) K924328

TRANSYSTEM LIQUID AMIES MEDIUM by Pro-Lab Diagnostics — Product Code LIO

K924328 is an FDA 510(k) premarket notification submitted by Pro-Lab Diagnostics for the device "TRANSYSTEM LIQUID AMIES MEDIUM". The FDA issued a decision of Substantially Equivalent on December 24, 1992. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Pro-Lab Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1992
Date Received
August 27, 1992
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 Pro-Lab Diagnostics

  • K944421 — E.COLI 0157 LATEX TEST (December 15, 1994)
  • K924330 — TRANSYSTEM AMIES WITH CHARCOAL (December 24, 1992)
  • K924331 — TRANSYSTEM LIQUID STUART MEDIUM (December 24, 1992)
  • K924329 — TRANSYSTEM AMIES W/O CHARCOAL (December 24, 1992)

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)
  • 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)

FDA data resources