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FDA 510(k)

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE

K-Number: K830309 · 1983-02-28

ApplicantEmd Chemicals, Inc.
Decision Date1983-02-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K830309. 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 ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE?

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830309.

When did ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE receive FDA 510(k) clearance?

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE received FDA 510(k) clearance on 1983-02-28, under 510(k) number K830309.

Who is the listed applicant for ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE?

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

What is the FDA product code for ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE?

The FDA product code for ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE is CHH.

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Other records listing Emd Chemicals, Inc. as applicant

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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

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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