APAS Independence with IC Chromogenic MRSA BD Analysis Module +1 more— 510(k) K200839

Name: FDA 510(k) clearance K200839
Creator: U.S. Food and Drug Administration
Published: 2021-10-28

Substantially Equivalent

Clever Culture Systems

FDA 510(k) clearance K200839 for APAS Independence with IC Chromogenic MRSA BD Analysis Module +1 more, Substantially Equivalent on 2021-10-28. Applicant: Clever Culture Systems. Device class: 2.

Clearance details

Device name as filed: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
Applicant: Clever Culture Systems
Product code: Code QQY
Device class: Class 2
Regulation: 21 CFR 866.2190
Advisory panel: Microbiology
Date received: 2020-03-31
Decision date: 2021-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bach, CH

Download summary PDF View on FDA.gov ↗

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