BOEHRINGER MANNHEIM IGM ASSAY— 510(k) K955908

Name: FDA 510(k) clearance K955908
Creator: U.S. Food and Drug Administration
Published: 1996-02-09

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K955908 for BOEHRINGER MANNHEIM IGM ASSAY, Substantially Equivalent on 1996-02-09. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DAO
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1995-12-29
Decision date: 1996-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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