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FDA 510(k)

ESKAFLOW TEST FOR TRIGLYCERIDES

K-Number: K811850 · 1981-07-23

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-07-23
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESKAFLOW TEST FOR TRIGLYCERIDES is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811850. 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 ESKAFLOW TEST FOR TRIGLYCERIDES?

ESKAFLOW TEST FOR TRIGLYCERIDES is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K811850.

When did ESKAFLOW TEST FOR TRIGLYCERIDES receive FDA 510(k) clearance?

ESKAFLOW TEST FOR TRIGLYCERIDES received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811850.

Who is the listed applicant for ESKAFLOW TEST FOR TRIGLYCERIDES?

The FDA 510(k) record lists Smithkline Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESKAFLOW TEST FOR TRIGLYCERIDES?

The FDA product code for ESKAFLOW TEST FOR TRIGLYCERIDES is CDT.

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Related Devices (Code: CDT)

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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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