ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347— 510(k) K983503

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K983503 for ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347, Substantially Equivalent on 1998-12-01. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant
Boehringer Mannheim Corp.
Product code
Code CEO
Device class
Class 1
Regulation
21 CFR 862.1580
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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