Cleared Traditional

BOEHRINGER MANNHEIM IGG ASSAY

K955906 · Boehringer Mannheim Corp. · Immunology
Feb 1996
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K955906 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM IGG ASSAY, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 9, 1996, 42 days after receiving the submission on December 29, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K955906 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1995
Decision Date February 09, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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