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FDA 510(k)

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module

K-Number: K200839 · 2021-10-28

ApplicantClever Culture Systems
Decision Date2021-10-28
Product CodeQQY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is a medical device manufactured by Clever Culture Systems. It received FDA 510(k) clearance on 2021-10-28 under approval number K200839. The device is classified under product code QQY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Clever Culture Systems. The 510(k) number is K200839.

When was APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module approved by the FDA?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module received FDA 510(k) clearance on 2021-10-28, under approval number K200839.

What company makes APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is manufactured by Clever Culture Systems.

What is the FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

The FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is QQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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