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FDA 510(k)

TRIGLYCERIDE ENZYMATIC METHOD

K-Number: K770841 · 1977-07-14

ApplicantUnion Carbide Corp.
Decision Date1977-07-14
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE ENZYMATIC METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K770841. 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 TRIGLYCERIDE ENZYMATIC METHOD?

TRIGLYCERIDE ENZYMATIC METHOD is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Union Carbide Corp.. The 510(k) number is K770841.

When did TRIGLYCERIDE ENZYMATIC METHOD receive FDA 510(k) clearance?

TRIGLYCERIDE ENZYMATIC METHOD received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770841.

Who is the listed applicant for TRIGLYCERIDE ENZYMATIC METHOD?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDE ENZYMATIC METHOD?

The FDA product code for TRIGLYCERIDE ENZYMATIC METHOD 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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