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FDA 510(k)

ULTRACHEM ENZYMATIC CHOL. OXIDASE

K-Number: K822418 · 1982-09-14

ApplicantEmd Chemicals, Inc.
Decision Date1982-09-14
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM ENZYMATIC CHOL. 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 1982-09-14 under 510(k) number K822418. 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 ULTRACHEM ENZYMATIC CHOL. OXIDASE?

ULTRACHEM ENZYMATIC CHOL. OXIDASE is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K822418.

When did ULTRACHEM ENZYMATIC CHOL. OXIDASE receive FDA 510(k) clearance?

ULTRACHEM ENZYMATIC CHOL. OXIDASE received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822418.

Who is the listed applicant for ULTRACHEM ENZYMATIC CHOL. 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 ULTRACHEM ENZYMATIC CHOL. OXIDASE?

The FDA product code for ULTRACHEM ENZYMATIC CHOL. OXIDASE is CHH.

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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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