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FDA 510(k)

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS

K-Number: K080459 · 2009-11-17

ApplicantChromsystems Instruments & Chemicals GmbH
Decision Date2009-11-17
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Chromsystems Instruments & Chemicals GmbH. It received FDA 510(k) clearance on 2009-11-17 under 510(k) number K080459. 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 CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS?

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Chromsystems Instruments & Chemicals GmbH. The 510(k) number is K080459.

When did CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS receive FDA 510(k) clearance?

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 2009-11-17, under 510(k) number K080459.

Who is the listed applicant for CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS?

The FDA 510(k) record lists Chromsystems Instruments & Chemicals GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS?

The FDA product code for CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS is LAS.

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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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.K030616CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5Microgenics Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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