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510(k) K213280

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App by Bd Kiestra B.V. — Product Code QQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
October 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Device Class
Class II
Regulation Number
866.2190
Review Panel
MI
Submission Type

Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.

Other clearances for product code QQY

  • K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence (October 28, 2021)