FASTCHEM BUN— 510(k) K771923

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K771923 for FASTCHEM BUN, Substantially Equivalent on 1977-11-11. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1977-10-13
Decision date: 1977-11-11
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.