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FDA 510(k)

DRI COTININE EIA ASSAY

K-Number: K030649 · 2003-05-22

ApplicantMicrogenics Corp.
Decision Date2003-05-22
Product CodeMRS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI COTININE EIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K030649. The device is classified under product code MRS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI COTININE EIA ASSAY?

DRI COTININE EIA ASSAY is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Microgenics Corp.. The 510(k) number is K030649.

When did DRI COTININE EIA ASSAY receive FDA 510(k) clearance?

DRI COTININE EIA ASSAY received FDA 510(k) clearance on 2003-05-22, under 510(k) number K030649.

Who is the listed applicant for DRI COTININE EIA ASSAY?

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

What is the FDA product code for DRI COTININE EIA ASSAY?

The FDA product code for DRI COTININE EIA ASSAY is MRS.

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Other records listing Microgenics Corp. as applicant

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Related Devices (Code: MRS)

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.

K021688NICALERTNymox Pharmaceutical CorporationK963733NICCHECK IDynagen, Inc.

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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