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FDA 510(k)

SIGMA PROCEDURE & REAGENT SYSTEM #335-UV

K-Number: K800301 · 1980-03-05

ApplicantSigma Chemical Co.
Decision Date1980-03-05
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE & REAGENT SYSTEM #335-UV is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1980-03-05 under 510(k) number K800301. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA PROCEDURE & REAGENT SYSTEM #335-UV?

SIGMA PROCEDURE & REAGENT SYSTEM #335-UV is a medical device that received FDA 510(k) clearance on 1980-03-05. The listed applicant is Sigma Chemical Co.. The 510(k) number is K800301.

When did SIGMA PROCEDURE & REAGENT SYSTEM #335-UV receive FDA 510(k) clearance?

SIGMA PROCEDURE & REAGENT SYSTEM #335-UV received FDA 510(k) clearance on 1980-03-05, under 510(k) number K800301.

Who is the listed applicant for SIGMA PROCEDURE & REAGENT SYSTEM #335-UV?

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

What is the FDA product code for SIGMA PROCEDURE & REAGENT SYSTEM #335-UV?

The FDA product code for SIGMA PROCEDURE & REAGENT SYSTEM #335-UV is CDT.

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Other records listing Sigma Chemical Co. as applicant

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K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, 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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