BOEHRINGER MANNHEIM BICARBONATE ASSAY— 510(k) K933461

Name: FDA 510(k) clearance K933461
Creator: U.S. Food and Drug Administration
Published: 1994-12-05

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K933461 for BOEHRINGER MANNHEIM BICARBONATE ASSAY, Substantially Equivalent on 1994-12-05. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1993-07-16
Decision date: 1994-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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