RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ Analyzer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K050100 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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