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FDA 510(k)

CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST

K-Number: K903126 · 1990-12-26

ApplicantCrystal Diagnostics, Inc.
Decision Date1990-12-26
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K903126. 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 CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST?

CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Crystal Diagnostics, Inc.. The 510(k) number is K903126.

When did CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST receive FDA 510(k) clearance?

CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST received FDA 510(k) clearance on 1990-12-26, under 510(k) number K903126.

Who is the listed applicant for CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST?

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

What is the FDA product code for CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST?

The FDA product code for CHOLESTAT(TM) WHOLE BLOOD 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 Crystal Diagnostics, 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.

K910240CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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