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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 the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2019-12-09 under 510(k) 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. The listed applicant is Microgenics Corporation. The 510(k) number is K190968.

When did CEDIA Benzodiazepine Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for CEDIA Benzodiazepine Assay?

The FDA 510(k) record lists Microgenics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEDIA Benzodiazepine Assay?

The FDA product code for CEDIA Benzodiazepine Assay is JXM.

Other records listing Microgenics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JXM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLCK153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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