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FDA 510(k)

GLUCOSE TEST

K-Number: K781342 · 1978-08-31

ApplicantWako Intl., Inc.
Decision Date1978-08-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wako Intl., Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781342. 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 GLUCOSE TEST?

GLUCOSE TEST is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Wako Intl., Inc.. The 510(k) number is K781342.

When did GLUCOSE TEST receive FDA 510(k) clearance?

GLUCOSE TEST received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781342.

Who is the listed applicant for GLUCOSE TEST?

The FDA 510(k) record lists Wako Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE TEST?

The FDA product code for GLUCOSE TEST 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 Intl., Inc. 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.

K790768WAKO CHOLESTEROL TESTK781899UREA NITROGEN TESTK781629SERI-SEP SERUM/PLASMA ISLOLATOR

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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