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FDA 510(k)

SALIVA ALCOHOL TEST

K-Number: K894001 · 1990-04-05

ApplicantEnzymatics C/O Burditt,Bowles,Radzius & Ruberry
Decision Date1990-04-05
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SALIVA ALCOHOL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. It received FDA 510(k) clearance on 1990-04-05 under 510(k) number K894001. 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 SALIVA ALCOHOL TEST?

SALIVA ALCOHOL TEST is a medical device that received FDA 510(k) clearance on 1990-04-05. The listed applicant is Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. The 510(k) number is K894001.

When did SALIVA ALCOHOL TEST receive FDA 510(k) clearance?

SALIVA ALCOHOL TEST received FDA 510(k) clearance on 1990-04-05, under 510(k) number K894001.

Who is the listed applicant for SALIVA ALCOHOL TEST?

The FDA 510(k) record lists Enzymatics C/O Burditt,Bowles,Radzius & Ruberry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALIVA ALCOHOL TEST?

The FDA product code for SALIVA ALCOHOL TEST is DIC.

Related Clinical Trials

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Other records listing Enzymatics C/O Burditt,Bowles,Radzius & Ruberry 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.

K911692ENZYMATICS, INC., TOTAL CHOLESTEROL TESTK903235STATLAB A-350 SALIVA ALCOHOL TEST

Related Devices (Code: DIC)

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.

K250609Sober Self-TestSober Ip, LLCK181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis CorporationK121247ALCO-SCREENChematics, Inc.K121256ALCO-SCREEN 02Chematics, Inc.K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics

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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