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510(k) K962201

Device
Quantex Igm
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K962201
Product code
DFT
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-25
Date received
1996-06-07
Regulation
866.5550
Classification name
Igm, 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
BETTY J LANE
Address
113 Hartwell Ave. Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DFT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983132IGMAbbott Laboratories1998-11-04
K955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.1996-04-05
K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems Group1994-12-12
K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.1990-04-12
K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, Inc.1989-08-02
K884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOrion Diagnostica, Inc.1988-10-27
K880828WAKO(TM) IGM-HA DIRECTWako Chemicals USA, Inc.1988-03-25
K873871IMMUNOGLOBULINS MUnipath , Ltd.1987-10-13
K872237KALLESTAD QM300 IGM ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-07-09
K871498TITAN GEL IMMUNOFIX CONTROLSHelena Laboratories1987-04-29
K862762TINA-QUANT(R) IGMBoehringer Mannheim Corp.1986-09-08
K855010QUANTIMETRIC PLUS IGM REAGENT KITKallestad Laboratories, Inc.1986-02-28
K853469GILFORD IMMUNOGLOBULIN M REAGENTGilford1985-09-16
K842327AMER. HISTO-ID SYS PRIMARY IGM S7920-31Bartels Immunodiagnostic Supplies, Inc.1984-08-02
K841814OPTIMATE IGM TESTMiles Laboratories, Inc.1984-06-22