Rotag Fructosamine (Glycated Protein) Assay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K900718 ↗

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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  Class II

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  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

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  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

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  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

See all devices from Roche Diagnostic Systems, Inc. →