Bun-Reative

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K760430 ↗

FDA Product Code

CDS

Device Class

Class II

Regulation

21 CFR Part 862.1770

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Boehringer Mannheim Corp. →

• What is the primary function of the Bun-Reative electrode?

  The Bun-Reative is an ion specific electrode designed specifically for clinical chemistry applications to measure urea nitrogen levels in patient samples.

• Who is the manufacturer of this device?

  The Bun-Reative is manufactured by Boehringer Mannheim Corp., located in McHenry, Illinois.

• What is the regulatory status of the Bun-Reative?

  The Bun-Reative is identified by FDA 510(k) number K760430 and is classified under regulation number 862.1770 within the clinical chemistry medical specialty.