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FDA 510(k)

CEDIA Benzodiazepine Assay

K-Number: K190968 · 2019-12-09

ApplicantMicrogenics Corporation
Decision Date2019-12-09
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA Benzodiazepine Assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2019-12-09 under approval number K190968. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA Benzodiazepine Assay?

CEDIA Benzodiazepine Assay is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Microgenics Corporation. The 510(k) number is K190968.

When was CEDIA Benzodiazepine Assay approved by the FDA?

CEDIA Benzodiazepine Assay received FDA 510(k) clearance on 2019-12-09, under approval number K190968.

What company makes CEDIA Benzodiazepine Assay?

CEDIA Benzodiazepine Assay is manufactured by Microgenics Corporation.

What is the FDA product code for CEDIA Benzodiazepine Assay?

The FDA product code for CEDIA Benzodiazepine Assay is JXM.

Other Devices by Microgenics Corporation

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Related Devices (Code: JXM)

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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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