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FDA 510(k)

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03

K-Number: K955633 · 1996-05-24

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-05-24
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 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 1996-05-24 under 510(k) number K955633. 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 ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03?

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K955633.

When did ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 receive FDA 510(k) clearance?

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 received FDA 510(k) clearance on 1996-05-24, under 510(k) number K955633.

Who is the listed applicant for ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03?

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 ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03?

The FDA product code for ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 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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