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FDA 510(k)

DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM

K-Number: K821315 · 1982-05-24

ApplicantThe Dow Chemical Co.
Decision Date1982-05-24
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM is the device name listed in this FDA 510(k) record. The listed applicant is The Dow Chemical Co.. It received FDA 510(k) clearance on 1982-05-24 under 510(k) number K821315. 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 DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM?

DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is The Dow Chemical Co.. The 510(k) number is K821315.

When did DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM receive FDA 510(k) clearance?

DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821315.

Who is the listed applicant for DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM?

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

What is the FDA product code for DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM?

The FDA product code for DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM is CDT.

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Other records listing The Dow 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.

K823474ENZYMATIC GLUCOSE DETERMINATIONK822154UREA NITROGEN (ENZYMATIC) DETERMINATIONK821536DOWFLOW ALT-UV DETERMINATIONK820675BILIRUBIN(TOTAL) DETERMINATION CTMSK820714DOW BILIRUBIN(DIRECT) DETERMINATIONK812777DIRECT IRON REAGENT SET

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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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