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FDA 510(k)

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA

K-Number: K830239 · 1983-04-05

ApplicantEmd Chemicals, Inc.
Decision Date1983-04-05
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA 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 1983-04-05 under 510(k) number K830239. 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 OXIDA?

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830239.

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

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830239.

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

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 OXIDA?

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

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Other records listing Emd Chemicals, Inc. as applicant

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Related Devices (Code: CHH)

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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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