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510(k) K925703

Device
OPUS SEROLOGY CONTROLS
Applicant
PB DIAGNOSTICS, INC.
510(k) number
K925703
Product code
MJX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-04-08
Date received
1992-11-12
Regulation
862.1660
Classification name
Kit, Serological, Positive Control
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
M JOHANSEN
Address
151 University Ave. Westwood MA US 02090 02090

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MJX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101434AUDIT MICROCV PROCALCITONIN LINEARITYAalto Scientific, Ltd.2010-07-22
K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical Diagnostics2003-01-17
K974262SYSCOS IDC - G, IDC, BSC, IDC - GScantibodies Laboratory, Inc.1997-12-24
K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.1997-10-08
K970100TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLSimplicity Diagnostics, Inc.1997-03-10
K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONPb Diagnostic Systems, Inc.1994-03-07

Legacy Summary#

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FDA Review#

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