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FDA 510(k)

WAKO HDL CHOLESTEROL TEST

K-Number: K801834 · 1980-09-16

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

Device Summary

WAKO HDL CHOLESTEROL 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 K801834. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO HDL CHOLESTEROL TEST?

WAKO HDL CHOLESTEROL 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 K801834.

When did WAKO HDL CHOLESTEROL TEST receive FDA 510(k) clearance?

WAKO HDL CHOLESTEROL TEST received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801834.

Who is the listed applicant for WAKO HDL CHOLESTEROL 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 HDL CHOLESTEROL TEST?

The FDA product code for WAKO HDL CHOLESTEROL TEST is LBS.

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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 TESTK801891WAKO TRIGLYCERIDE-G TESTK801076WAKO PHOSPHOLIPIDS TESTK791597WAKO TRIGLYCERIDE

Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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