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FDA 510(k)

ETHYL ALCOHOL ASSAY

K-Number: K923783 · 1993-01-21

ApplicantDiagnostic Reagents, Inc.
Decision Date1993-01-21
Product CodeDMT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K923783. The device is classified under product code DMT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHYL ALCOHOL ASSAY?

ETHYL ALCOHOL ASSAY is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K923783.

When did ETHYL ALCOHOL ASSAY receive FDA 510(k) clearance?

ETHYL ALCOHOL ASSAY received FDA 510(k) clearance on 1993-01-21, under 510(k) number K923783.

Who is the listed applicant for ETHYL ALCOHOL ASSAY?

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

What is the FDA product code for ETHYL ALCOHOL ASSAY?

The FDA product code for ETHYL ALCOHOL ASSAY is DMT.

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Other records listing Diagnostic Reagents, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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Related Devices (Code: DMT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000410SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORSBeckman Coulter, Inc.K971506SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATORBeckman Instruments, Inc.K934273KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)Eastman Kodak CompanyK864894EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93Em Diagnostic Systems, Inc.K843378ETHYL ALCOHOL ASSAY KITDiagnostic Chemicals, Ltd. (Usa)K810467EMIT-ST SERUM ETHYL ALCOHOL ASSAYSyva Co.

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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