STAT K IN VITRO DIAGNOSTIC TEST SYSTEM— 510(k) K042270

Name: FDA 510(k) clearance K042270
Creator: U.S. Food and Drug Administration
Published: 2004-10-06

Substantially Equivalent

Stat Chem, Inc.

FDA 510(k) clearance K042270 for STAT K IN VITRO DIAGNOSTIC TEST SYSTEM, Substantially Equivalent on 2004-10-06. Applicant: Stat Chem, Inc.. Device class: 2.

Clearance details

Applicant: Stat Chem, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2004-08-23
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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