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FDA 510(k)

WAKO GLUCOSE C

K-Number: K842221 · 1984-07-12

ApplicantWako Pure Chemical Industries, Ltd.
Decision Date1984-07-12
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO GLUCOSE C 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 1984-07-12 under 510(k) number K842221. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO GLUCOSE C?

WAKO GLUCOSE C is a medical device that received FDA 510(k) clearance on 1984-07-12. The listed applicant is Wako Pure Chemical Industries, Ltd.. The 510(k) number is K842221.

When did WAKO GLUCOSE C receive FDA 510(k) clearance?

WAKO GLUCOSE C received FDA 510(k) clearance on 1984-07-12, under 510(k) number K842221.

Who is the listed applicant for WAKO GLUCOSE C?

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 GLUCOSE C?

The FDA product code for WAKO GLUCOSE C is CGA.

Related Clinical Trials

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.

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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.

K813366AMMONIA TESTK801891WAKO TRIGLYCERIDE-G TESTK801834WAKO HDL CHOLESTEROL TESTK801076WAKO PHOSPHOLIPIDS TESTK791597WAKO TRIGLYCERIDE

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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