CARESIDE HDL-CHOLESTEROL— 510(k) K981899

Name: FDA 510(k) clearance K981899
Creator: U.S. Food and Drug Administration
Published: 1998-07-14

Substantially Equivalent

Exigent Diagnostics, Inc.

FDA 510(k) clearance K981899 for CARESIDE HDL-CHOLESTEROL, Substantially Equivalent on 1998-07-14. Applicant: Exigent Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Exigent Diagnostics, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1998-06-01
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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