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Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total Ghb Program

by Bio-Rad Laboratories Inc., Clinical Systems Divisi 510(k)

Active United States

510(k) K063643

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK063643 Date27 Dec 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1395-2009 FDA Unclassified (pre-2012) initiated 9 Dec 2008

    The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

Specification

510(k)

510(k) Number
FDA Product Code
LCP
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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