DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Class II

FDA Device Classification

Classification Details

Product Code
DBL
Device Class
Class II
Regulation Number
866.5660
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K963525shield diagnosticsDIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITNovember 7, 1996
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K944192light diagnosticsANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVERMarch 6, 1995
K944191light diagnosticsANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVERMarch 6, 1995
K913360immco diagnosticsANTI-RETICULIN ANTIBODY (ARA) TESTSeptember 26, 1994
K912551immco diagnosticsANTI-ENDOMYSIAL ANTIBODY TESTJune 9, 1993
K904181biochemical diagnosticANTI-GBM ANTIBODIES QUANTITATIVE KITSeptember 10, 1991
K902237medicaMEDICA IIF ANTI-SKIN ANTIBODY TEST KITJuly 9, 1990
K891098immco diagnosticsANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)March 22, 1989
K891099immco diagnosticsANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)March 22, 1989
K883915immco diagnosticsAUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)October 19, 1988
K871194cronusI-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KITApril 20, 1987
K821576immuno-products industriesANTINUCLEAR ANTIBODY SCREEN FLOURESCJune 10, 1982
K820088calbiochem-behringAFT SYSTEM PROFICIENCY TESTING PROGRAMJanuary 26, 1982