CARESIDE TOTAL PROTEIN— 510(k) K980042

Name: FDA 510(k) clearance K980042
Creator: U.S. Food and Drug Administration
Published: 1998-02-04

Substantially Equivalent

Exigent Diagnostics, Inc.

FDA 510(k) clearance K980042 for CARESIDE TOTAL PROTEIN, Substantially Equivalent on 1998-02-04. Applicant: Exigent Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Exigent Diagnostics, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1998-01-06
Decision date: 1998-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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