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FDA 510(k)

SPIN-CHEM TRIGLYCERIDES REAGENT

K-Number: K812471 · 1981-09-14

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-09-14
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIN-CHEM TRIGLYCERIDES REAGENT 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 1981-09-14 under 510(k) number K812471. 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 SPIN-CHEM TRIGLYCERIDES REAGENT?

SPIN-CHEM TRIGLYCERIDES REAGENT is a medical device that received FDA 510(k) clearance on 1981-09-14. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K812471.

When did SPIN-CHEM TRIGLYCERIDES REAGENT receive FDA 510(k) clearance?

SPIN-CHEM TRIGLYCERIDES REAGENT received FDA 510(k) clearance on 1981-09-14, under 510(k) number K812471.

Who is the listed applicant for SPIN-CHEM TRIGLYCERIDES REAGENT?

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 SPIN-CHEM TRIGLYCERIDES REAGENT?

The FDA product code for SPIN-CHEM TRIGLYCERIDES REAGENT is CDT.

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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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