Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and Tdm Control Level 1, Model AP11001, Level 2, Model AP22002

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

510(k) Number

K980514 ↗

FDA Product Code

JJY

Models / Variants

AP11001

Level 2

Model AP22002

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Mas Lipid Level 1 and 2

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• Reflab System Pack Liquid Fructosamine Reagent

  Class II

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See all devices from Medical Analysis Systems, Inc. →