WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2— 510(k) K912826

Name: FDA 510(k) clearance K912826
Creator: U.S. Food and Drug Administration
Published: 1991-07-26

Substantially Equivalent

Cala Diagnostics

FDA 510(k) clearance K912826 for WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2, Substantially Equivalent on 1991-07-26. Applicant: Cala Diagnostics. Device class: 1.

Clearance details

Applicant: Cala Diagnostics
Product code: Code DKC
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1991-06-26
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Osos, CA, US

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