FDA.reportPublic FDA data

510(k) K955908

Device
BOEHRINGER MANNHEIM IGM ASSAY
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K955908
Product code
DAO  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-09
Date received
1995-12-29
Regulation
866.5550
Classification name
Igm (mu Chain Specific), Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN D STEVENS
Address
9115 Hague Rd., P.O. Box 50457 Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DAO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040431ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2Roche Diagnostics Corp.2004-03-10
K982639SPIFE URINE IFEHelena Laboratories1998-11-04
K850586SPQ TEST SYSTEM FOR IMMUNOGLOBULIN MApplications Lab1985-03-14
K841992MODIFICATION TO ACS CORONARY GUIDINGAdvanced Cardiovascular Systems, Inc.1984-06-11
K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDako Corp.1981-09-23
K800450GEMENI IGM ASSAYElectro-Nucleonics Laboratories, Inc.1980-04-24
K790705ANTISERUM TO HUMAN IGMKent Laboratories, Inc.1979-04-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases