VARIANT II TURBO HbA1c Kit - 2.0

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K142448 ↗

FDA Product Code

PDJ

Device Class

Class II

Regulation

21 CFR Part 862.1373

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Access(R) Total Ige Assay

  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

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  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

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