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510(k) K834349

Device
Anti-native Dna Antibody
Applicant
SIGMA CHEMICAL CO.
510(k) number
K834349
Product code
KTL
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-19
Date received
1983-12-13
Regulation
866.5100
Classification name
Anti-Dna Indirect Immunofluorescent Solid Phase
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, Inc.2002-04-11
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K990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYStellar Bio Systems, Inc.1999-04-21
K930987CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)The Binding Site, Ltd.1993-08-10
K905386DISTAT ANTI-DSDNA KITShield Diagnostics, Ltd.1990-12-13
K864275ANTI-NDNA ANTIBODY TEST KITCappel Diagnostics, Inc.1986-12-15
K861978AUTOFLUOR VTechnia Diagnostics , Ltd.1986-06-10
K842707ADP NDNA IFA TESTApple Diagnostic Products1984-08-21
K834140ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYSIntl. Diagnostic Technology1984-01-20
K833984ANTINUCLEAR ANTIBODY IMMUNOLOGICALIntl. Diagnostic Technology1984-01-04