CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1 - Level 2

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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See all devices from Medical Analysis Systems, Inc. →