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FDA 510(k)

TRIGLYCERIDES REAGENT SYSTEM

K-Number: K843832 · 1984-11-27

ApplicantFermco Biochemics, Inc.
Decision Date1984-11-27
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fermco Biochemics, Inc.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843832. 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 TRIGLYCERIDES REAGENT SYSTEM?

TRIGLYCERIDES REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Fermco Biochemics, Inc.. The 510(k) number is K843832.

When did TRIGLYCERIDES REAGENT SYSTEM receive FDA 510(k) clearance?

TRIGLYCERIDES REAGENT SYSTEM received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843832.

Who is the listed applicant for TRIGLYCERIDES REAGENT SYSTEM?

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

What is the FDA product code for TRIGLYCERIDES REAGENT SYSTEM?

The FDA product code for TRIGLYCERIDES REAGENT SYSTEM is CDT.

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Other records listing Fermco Biochemics, Inc. as applicant

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K823106RERMCO TEST CHLORIDE REAGENTK822117FERMCOTEST CO2 REAGNETK822118FERMCOTEST CREATININE TEST REAGENTK810567GERMCO TEST R GLUCOSE TEST KITK791066GLUCOSE GOD-PAP TRINDER METHOD TEST KITK791018FERMCOTEST R BUN RATE REAGENT TEST KIT

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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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