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FDA 510(k)

WAKO TRIGLYCERIDE-G TEST

K-Number: K801891 · 1980-09-16

ApplicantWako Pure Chemical Industries, Ltd.
Decision Date1980-09-16
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO TRIGLYCERIDE-G TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wako Pure Chemical Industries, Ltd.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801891. 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 WAKO TRIGLYCERIDE-G TEST?

WAKO TRIGLYCERIDE-G TEST is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Wako Pure Chemical Industries, Ltd.. The 510(k) number is K801891.

When did WAKO TRIGLYCERIDE-G TEST receive FDA 510(k) clearance?

WAKO TRIGLYCERIDE-G TEST received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801891.

Who is the listed applicant for WAKO TRIGLYCERIDE-G TEST?

The FDA 510(k) record lists Wako Pure Chemical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAKO TRIGLYCERIDE-G TEST?

The FDA product code for WAKO TRIGLYCERIDE-G TEST is CDT.

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Other records listing Wako Pure Chemical Industries, Ltd. 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.

K842221WAKO GLUCOSE CK813366AMMONIA TESTK801834WAKO HDL CHOLESTEROL TESTK801076WAKO PHOSPHOLIPIDS TESTK791597WAKO TRIGLYCERIDE

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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