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 |
| K180202 | Immuno Concepts, NA, Ltd. | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | 10/19/2018 |
| 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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