VARIANT(TM) II TURBO HBA1C KIT - 2.0— 510(k) K130990

Name: FDA 510(k) clearance K130990
Creator: U.S. Food and Drug Administration
Published: 2013-05-09

Substantially Equivalent

Bio-Rad Laboratories, Inc., Clinical Systems Divis

FDA 510(k) clearance K130990 for VARIANT(TM) II TURBO HBA1C KIT - 2.0, Substantially Equivalent on 2013-05-09. Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2013-04-10
Decision date: 2013-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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