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FDA 510(k)

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

K-Number: K172255 · 2017-12-01

ApplicantBeckman Coulter, Inc.
Decision Date2017-12-01
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2017-12-01 under approval number K172255. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)?

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K172255.

When was MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) approved by the FDA?

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) received FDA 510(k) clearance on 2017-12-01, under approval number K172255.

What company makes MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)?

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) is manufactured by Beckman Coulter, Inc..

What is the FDA product code for MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)?

The FDA product code for MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) is LTT.

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Related Devices (Code: LTT)

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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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