STATLAB A-350 SALIVA ALCOHOL TEST— 510(k) K903235

Name: FDA 510(k) clearance K903235
Creator: U.S. Food and Drug Administration
Published: 1990-10-12

Substantially Equivalent

Enzymatics C/O Burditt,Bowles,Radzius & Ruberry

FDA 510(k) clearance K903235 for STATLAB A-350 SALIVA ALCOHOL TEST, Substantially Equivalent on 1990-10-12. Applicant: Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. Device class: 2.

Clearance details

Applicant: Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1990-07-23
Decision date: 1990-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Download summary PDF View on FDA.gov ↗

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