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FDA 510(k)

MASSTRAK IMMUNOSUPPRESSANTS KIT

K-Number: K063868 · 2007-05-25

ApplicantWaters Corporation
Decision Date2007-05-25
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MASSTRAK IMMUNOSUPPRESSANTS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Waters Corporation. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K063868. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASSTRAK IMMUNOSUPPRESSANTS KIT?

MASSTRAK IMMUNOSUPPRESSANTS KIT is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Waters Corporation. The 510(k) number is K063868.

When did MASSTRAK IMMUNOSUPPRESSANTS KIT receive FDA 510(k) clearance?

MASSTRAK IMMUNOSUPPRESSANTS KIT received FDA 510(k) clearance on 2007-05-25, under 510(k) number K063868.

Who is the listed applicant for MASSTRAK IMMUNOSUPPRESSANTS KIT?

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

What is the FDA product code for MASSTRAK IMMUNOSUPPRESSANTS KIT?

The FDA product code for MASSTRAK IMMUNOSUPPRESSANTS KIT is MLM.

Related Clinical Trials

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Other records listing Waters 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.

K9801802700 SAMPLE MANAGERK9730742487 DUAL WAVELENGTH ABSORBANCE DETECTORK964588WATERS 515 HPLC PUMP (515)K962574WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)K961557ALLIANCE 2690 SEPARATIONS MODULE

Related Devices (Code: MLM)

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.

K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.K173857Elecsys TacrolimusRoche DiagnosticsK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSMicrogenics Corp.K070820ARCHITECT TACROLIMUS: MODEL 1L77Fujirebio Diagnostics,Inc.K060502DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107Dade Behring, Inc.K060385EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENTDade Behring, Inc.

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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