DBL · Class II · 21 CFR 866.5660

FDA Product Code DBL: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Immco Diagnostics, Inc., Light Diagnostics and Scimedx Corp..

24
Total
24
Cleared
178d
Avg days
1980
Since

FDA 510(k) Cleared Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DBL)

24 devices
1–24 of 24
Cleared Oct 19, 2018
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
K180202
Immuno Concepts, N.A. , Ltd.
Immunology · 268d
Cleared Apr 02, 1998
NOVA LITE ENDOMYSIAL
K980312
Inova Diagnostics, Inc.
Immunology · 65d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169
Wieslab AB
Immunology · 104d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
K971464
Euro-Diagnostica AB
Immunology · 190d
Cleared May 23, 1997
MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
K971658
Jay H. Geller
Immunology · 39d
Cleared Nov 07, 1996
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
K963525
Shield Diagnostics, Ltd.
Immunology · 64d
Cleared Apr 23, 1996
RIT LIVER, KIDNEY, STOMACH IFA KIT
K955431
The Binding Site, Ltd.
Immunology · 147d
Cleared Apr 10, 1996
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
K953495
Scimedx Corp.
Immunology · 259d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
K944191
Light Diagnostics
Immunology · 189d
Cleared Mar 06, 1995
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
K944192
Light Diagnostics
Immunology · 189d
Cleared Sep 26, 1994
ANTI-RETICULIN ANTIBODY (ARA) TEST
K913360
Immco Diagnostics, Inc.
Immunology · 1155d
Cleared Jun 09, 1993
ANTI-ENDOMYSIAL ANTIBODY TEST
K912551
Immco Diagnostics, Inc.
Immunology · 729d
Cleared Jul 09, 1990
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
K902237
Medica Corp.
Immunology · 52d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
K891098
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Mar 22, 1989
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)
K891099
Immco Diagnostics, Inc.
Immunology · 20d
Cleared Oct 19, 1988
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
K883915
Immco Diagnostics, Inc.
Immunology · 33d
Cleared Jan 26, 1982
AFT SYSTEM PROFICIENCY TESTING PROGRAM
K820088
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Aug 12, 1981
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261
Zeus Scientific, Inc.
Microbiology · 98d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610
Kallestad Laboratories, Inc.
Immunology · 66d

About Product Code DBL - Regulatory Context