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FDA 510(k)

EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93

K-Number: K864894 · 1987-01-09

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-01-09
Product CodeDMT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K864894. 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 EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93?

EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K864894.

When did EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 receive FDA 510(k) clearance?

EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 received FDA 510(k) clearance on 1987-01-09, under 510(k) number K864894.

Who is the listed applicant for EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93?

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

What is the FDA product code for EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93?

The FDA product code for EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 is DMT.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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.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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