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FDA 510(k)

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17

K-Number: K993920 · 2000-01-18

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2000-01-18
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K993920. 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 ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17?

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K993920.

When did ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 receive FDA 510(k) clearance?

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 received FDA 510(k) clearance on 2000-01-18, under 510(k) number K993920.

Who is the listed applicant for ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17?

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

What is the FDA product code for ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17?

The FDA product code for ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 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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