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510(k) K850586

Device
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
Applicant
APPLICATIONS LAB
510(k) number
K850586
Product code
DAO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-14
Date received
1985-02-13
Regulation
866.5550
Classification name
Igm (mu Chain Specific), Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GLENN R IRISH
Address
10 Nonesuch Rd. Scarborough ME US 04074 04074

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
K982639SPIFE URINE IFEHelena Laboratories1998-11-04
K955908BOEHRINGER MANNHEIM IGM ASSAYBoehringer Mannheim Corp.1996-02-09
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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