FDA 510(k) Applications for Medical Device Product Code "DBL"
(Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K904181 BIOCHEMICAL DIAGNOSTIC, INC. ANTI-GBM ANTIBODIES QUANTITATIVE KIT 09/10/1991
K820088 CALBIOCHEM-BEHRING CORP. AFT SYSTEM PROFICIENCY TESTING PROGRAM 01/26/1982
K871194 CRONUS I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT 04/20/1987
K971464 EURO-DIAGNOSTICA AB IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT 10/29/1997
K912551 IMMCO DIAGNOSTICS, INC. ANTI-ENDOMYSIAL ANTIBODY TEST 06/09/1993
K913360 IMMCO DIAGNOSTICS, INC. ANTI-RETICULIN ANTIBODY (ARA) TEST 09/26/1994
K891098 IMMCO DIAGNOSTICS, INC. ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) 03/22/1989
K891099 IMMCO DIAGNOSTICS, INC. ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) 03/22/1989
K883915 IMMCO DIAGNOSTICS, INC. AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) 10/19/1988
K801960 IMMUNO-DIAGNOSTIC PRODUCTS, INC. ANTI-DS/N-DNA TEST KIT 10/10/1980
K821576 IMMUNO-PRODUCTS INDUSTRIES ANTINUCLEAR ANTIBODY SCREEN FLOURESC 06/10/1982
K980312 INOVA DIAGNOSTICS, INC. NOVA LITE ENDOMYSIAL 04/02/1998
K971658 JAY H. GELLER MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT 05/23/1997
K792610 KALLESTAD LABORATORIES, INC. KALLESTAD FLORESCENT ANA/AMA/ASMA TEST 02/22/1980
K944192 LIGHT DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER 03/06/1995
K944191 LIGHT DIAGNOSTICS ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER 03/06/1995
K791996 MEDA STAT DIAGNOSTICS, INC. MULTIPLE AUTO ANTIBODY TEST 01/16/1980
K902237 MEDICA CORP. MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT 07/09/1990
K953495 SCIMEDX CORP. EIA KIT FOR THE DETECTION OF GBM ANTIBODIES 04/10/1996
K963525 SHIELD DIAGNOSTICS, LTD. DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT 11/07/1996
K955431 THE BINDING SITE, LTD. RIT LIVER, KIDNEY, STOMACH IFA KIT 04/23/1996
K974169 WIESLAB AB WIELISA ANTI-GBM TEST SYSTEM 02/17/1998
K811261 ZEUS SCIENTIFIC, INC. ANTI-SKIN ANTIBODY TEST SYSTEM 08/12/1981


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