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FDA 510(k)

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12

K-Number: K974002 · 1998-04-01

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-04-01
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 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 1998-04-01 under 510(k) number K974002. 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-SL ASSAY, CATALOGUE NUMBER 240-12?

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K974002.

When did ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 receive FDA 510(k) clearance?

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 received FDA 510(k) clearance on 1998-04-01, under 510(k) number K974002.

Who is the listed applicant for ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12?

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-SL ASSAY, CATALOGUE NUMBER 240-12?

The FDA product code for ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 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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