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 |