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510(k) K142448

VARIANT II TURBO HbA1c Kit - 2.0 by Bio-Rad Laboratories, Inc. — Product Code PDJ

K142448 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "VARIANT II TURBO HbA1c Kit - 2.0". The FDA issued a decision of Substantially Equivalent on March 24, 2015. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2015
Date Received
September 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

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  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)

Other clearances for product code PDJ

  • K252749 — Medconn 8K Glycated Hemoglobin Test System (January 6, 2026)
  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K242911 — Medconn Glycated Hemoglobin Test system (June 20, 2025)
  • K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System (September 12, 2024)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)

FDA data resources