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FDA 510(k)

ETHYL ALCOHOL ASSAY KIT

K-Number: K843378 · 1984-09-14

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-09-14
Product CodeDMT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K843378. 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 KIT?

ETHYL ALCOHOL ASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K843378.

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

ETHYL ALCOHOL ASSAY KIT received FDA 510(k) clearance on 1984-09-14, under 510(k) number K843378.

Who is the listed applicant for ETHYL ALCOHOL ASSAY KIT?

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

What is the FDA product code for ETHYL ALCOHOL ASSAY KIT?

The FDA product code for ETHYL ALCOHOL ASSAY KIT is DMT.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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 CompanyK923783ETHYL ALCOHOL ASSAYDiagnostic Reagents, Inc.K864894EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93Em Diagnostic Systems, Inc.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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