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510(k) K982639

Device
SPIFE URINE IFE
Applicant
HELENA LABORATORIES
510(k) number
K982639
Product code
DAO  
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-04
Date received
1998-07-29
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K955908BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.1996-02-09
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#

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FDA Review#

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