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FDA 510(k)

THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

K-Number: K101745 · 2011-04-08

ApplicantMicrogenics Corp.
Decision Date2011-04-08
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT 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 2011-04-08 under 510(k) number K101745. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY?

THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Microgenics Corp.. The 510(k) number is K101745.

When did THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY receive FDA 510(k) clearance?

THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY received FDA 510(k) clearance on 2011-04-08, under 510(k) number K101745.

Who is the listed applicant for THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT 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 THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY?

The FDA product code for THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY is DKZ.

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Other records listing Microgenics Corp. 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, 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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