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510(k) K221493

MicroScan Prompt Inoculation System-D by Beckman Coulter, Inc. — Product Code LIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
May 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent/Device, Inoculum Calibration
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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Other clearances for product code LIE

  • K103456 — THE SENSITITRE AIM (June 22, 2011)
  • K110331 — SENSITITRE AIM (TM) (April 27, 2011)
  • K935566 — SENSI-CAL AMCO AEPA-1 (March 29, 1994)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K890339 — DIFCO DIRECTOR INOCULATION SYSTEM (February 7, 1989)
  • K820299 — PROMPT INOCULATION SYSTEM (March 15, 1982)