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510(k) K843000

MICRO ORGANISM GROWTH SYS-M1000 by Hml Inc/Biotechnology Transfer — Product Code LIO

K843000 is an FDA 510(k) premarket notification submitted by Hml Inc/Biotechnology Transfer for the device "MICRO ORGANISM GROWTH SYS-M1000". The FDA issued a decision of Substantially Equivalent on February 6, 1985. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Hml Inc/Biotechnology Transfer has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1985
Date Received
July 30, 1984
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 Hml Inc/Biotechnology Transfer

  • K842310 — HEMATOLOGY ANALYZER (September 6, 1984)
  • K842311 — CHEMISTRY ANALYZER, GEN. PURPOSE (July 25, 1984)

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