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FDA 510(k)

MICROGENICS CYCLOSPORINE CONTROL KIT

K-Number: K032842 · 2003-10-17

ApplicantMicrogenics Corp.
Decision Date2003-10-17
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROGENICS CYCLOSPORINE CONTROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2003-10-17 under 510(k) number K032842. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROGENICS CYCLOSPORINE CONTROL KIT?

MICROGENICS CYCLOSPORINE CONTROL KIT is a medical device that received FDA 510(k) clearance on 2003-10-17. The listed applicant is Microgenics Corp.. The 510(k) number is K032842.

When did MICROGENICS CYCLOSPORINE CONTROL KIT receive FDA 510(k) clearance?

MICROGENICS CYCLOSPORINE CONTROL KIT received FDA 510(k) clearance on 2003-10-17, under 510(k) number K032842.

Who is the listed applicant for MICROGENICS CYCLOSPORINE CONTROL KIT?

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 MICROGENICS CYCLOSPORINE CONTROL KIT?

The FDA product code for MICROGENICS CYCLOSPORINE CONTROL KIT is LAS.

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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: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K030616CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5Microgenics Corp.

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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