BUN-REATIVE— 510(k) K760430

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K760430 for BUN-REATIVE, Substantially Equivalent on 1976-11-01. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDS
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1976-08-13
Decision date: 1976-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.