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FDA 510(k)

CHOLESTEROL, UNIVERSAL ET

K-Number: K896073 · 1989-12-12

ApplicantEnzyme Technology, Inc.
Decision Date1989-12-12
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL, UNIVERSAL ET is the device name listed in this FDA 510(k) record. The listed applicant is Enzyme Technology, Inc.. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K896073. 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 CHOLESTEROL, UNIVERSAL ET?

CHOLESTEROL, UNIVERSAL ET is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Enzyme Technology, Inc.. The 510(k) number is K896073.

When did CHOLESTEROL, UNIVERSAL ET receive FDA 510(k) clearance?

CHOLESTEROL, UNIVERSAL ET received FDA 510(k) clearance on 1989-12-12, under 510(k) number K896073.

Who is the listed applicant for CHOLESTEROL, UNIVERSAL ET?

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

What is the FDA product code for CHOLESTEROL, UNIVERSAL ET?

The FDA product code for CHOLESTEROL, UNIVERSAL ET is CHH.

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Other records listing Enzyme Technology, 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.

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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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