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FDA 510(k)

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

K-Number: K190109 · 2019-04-18

ApplicantBeckman Coulter, Inc.
Decision Date2019-04-18
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2019-04-18 under approval number K190109. The device is classified under product code JWY. 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 Eravacycline (ERV) (0.016-32 ug/mL)?

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K190109.

When was MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) approved by the FDA?

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) received FDA 510(k) clearance on 2019-04-18, under approval number K190109.

What company makes MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)?

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) is manufactured by Beckman Coulter, Inc..

What is the FDA product code for MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)?

The FDA product code for MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) is JWY.

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Related Devices (Code: JWY)

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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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