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FDA 510(k)

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

K-Number: K250036 · 2025-08-15

ApplicantBeckman Coulter, Inc.
Decision Date2025-08-15
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-08-15 under approval number K250036. 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-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)?

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K250036.

When was MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) approved by the FDA?

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) received FDA 510(k) clearance on 2025-08-15, under approval number K250036.

What company makes MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)?

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) is manufactured by Beckman Coulter, Inc..

What is the FDA product code for MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)?

The FDA product code for MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/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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