ALB OR ALBUMIN— 510(k) K971445

Name: FDA 510(k) clearance K971445
Creator: U.S. Food and Drug Administration
Published: 1997-05-02

Substantially Equivalent

Carolina Liquid Chemistries Corp.

FDA 510(k) clearance K971445 for ALB OR ALBUMIN, Substantially Equivalent on 1997-05-02. Applicant: Carolina Liquid Chemistries Corp.. Device class: 2.

Clearance details

Applicant: Carolina Liquid Chemistries Corp.
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1997-04-21
Decision date: 1997-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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