Deoxypyridinoline Assay for the Bayer Immuno 1 System

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K972580 ↗

FDA Product Code

JMM

Device Class

Class I

Regulation

21 CFR Part 862.1400

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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