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FDA 510(k)

WAKO CHOLESTEROL TEST

K-Number: K790768 · 1979-05-23

ApplicantWako Intl., Inc.
Decision Date1979-05-23
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO CHOLESTEROL 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 1979-05-23 under 510(k) number K790768. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO CHOLESTEROL TEST?

WAKO CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1979-05-23. The listed applicant is Wako Intl., Inc.. The 510(k) number is K790768.

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

WAKO CHOLESTEROL TEST received FDA 510(k) clearance on 1979-05-23, under 510(k) number K790768.

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

The FDA product code for WAKO CHOLESTEROL TEST is CHH.

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.

K781899UREA NITROGEN TESTK781629SERI-SEP SERUM/PLASMA ISLOLATORK781342GLUCOSE TEST

Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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