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FDA 510(k)

ENZYMATIC TRIGLYCERIDES REAGENT KIT

K-Number: K781240 · 1978-08-17

ApplicantJ.T. Baker Chemical Co.
Decision Date1978-08-17
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC TRIGLYCERIDES REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1978-08-17 under 510(k) number K781240. 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 ENZYMATIC TRIGLYCERIDES REAGENT KIT?

ENZYMATIC TRIGLYCERIDES REAGENT KIT is a medical device that received FDA 510(k) clearance on 1978-08-17. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K781240.

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

ENZYMATIC TRIGLYCERIDES REAGENT KIT received FDA 510(k) clearance on 1978-08-17, under 510(k) number K781240.

Who is the listed applicant for ENZYMATIC TRIGLYCERIDES REAGENT KIT?

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

What is the FDA product code for ENZYMATIC TRIGLYCERIDES REAGENT KIT?

The FDA product code for ENZYMATIC TRIGLYCERIDES REAGENT KIT is CDT.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

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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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