URINARY/CSF PROTEIN— 510(k) K913615

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K913615 for URINARY/CSF PROTEIN, Substantially Equivalent on 1991-09-13. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JGQ
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1991-08-13
Decision date: 1991-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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