Cleared Traditional

BOEHRINGER MANNHEIM IGM ASSAY

K955908 · Boehringer Mannheim Corp. · Immunology
Feb 1996
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K955908 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM IGM ASSAY, a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DAO), 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 866.5550.

Submission Details

510(k) Number K955908 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 DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

Similar Devices — DAO Igm (mu Chain Specific), Antigen, Antiserum, Control

All 7
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
K040431 · Roche Diagnostics Corp. · Mar 2004
SPIFE URINE IFE
K982639 · Helena Laboratories · Nov 1998
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
K850586 · Applications Lab · Mar 1985
MODIFICATION TO ACS CORONARY GUIDING
K841992 · Advanced Cardiovascular Systems, Inc. · Jun 1984
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
K812487 · Dako Corp. · Sep 1981
GEMENI IGM ASSAY
K800450 · Electro-Nucleonics Laboratories, Inc. · Apr 1980