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FDA 510(k)

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221

K-Number: K032461 · 2003-10-03

ApplicantLin-Zhi International, Inc.
Decision Date2003-10-03
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2003-10-03 under 510(k) number K032461. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221?

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 is a medical device that received FDA 510(k) clearance on 2003-10-03. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K032461.

When did ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 receive FDA 510(k) clearance?

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 received FDA 510(k) clearance on 2003-10-03, under 510(k) number K032461.

Who is the listed applicant for ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221?

The FDA product code for ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 is DIC.

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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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