QUALITY CONTROL MATERIAL (ASSAYED)— 510(k) K935819

Name: FDA 510(k) clearance K935819
Creator: U.S. Food and Drug Administration
Published: 1994-03-22

Substantially Equivalent

Columbia Diagnostics, Inc.

FDA 510(k) clearance K935819 for QUALITY CONTROL MATERIAL (ASSAYED), Substantially Equivalent on 1994-03-22. Applicant: Columbia Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Columbia Diagnostics, Inc.
Product code: Code DKC
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1993-12-03
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, VA, US

Download summary PDF View on FDA.gov ↗

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