MODIFICATION TO ALPHA DX SYSTEM— 510(k) K013118

Name: FDA 510(k) clearance K013118
Creator: U.S. Food and Drug Administration
Published: 2001-10-15

Substantially Equivalent

First Medical, Inc.

FDA 510(k) clearance K013118 for MODIFICATION TO ALPHA DX SYSTEM, Substantially Equivalent on 2001-10-15. Applicant: First Medical, Inc.. Device class: 2.

Clearance details

Applicant: First Medical, Inc.
Product code: Code JHX
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2001-09-18
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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