METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK— 510(k) K042336

Name: FDA 510(k) clearance K042336
Creator: U.S. Food and Drug Administration
Published: 2004-10-14

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K042336 for METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK, Substantially Equivalent on 2004-10-14. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2004-08-30
Decision date: 2004-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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