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510(k) K200839

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module by Clever Culture Systems — Product Code QQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2021
Date Received
March 31, 2020
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 by Clever Culture Systems

  • K183648 — APAS Independence with Urine Analysis Module (May 15, 2019)
  • DEN150059 — APAS Compact with Urine Analysis Module (October 6, 2016)

Other clearances for product code QQY

  • K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD K (May 4, 2023)