Panels › Immunology › Product code DBL · Class 2
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5660
0510(k)s in 12 months (24 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Immco Diagnostics, Inc. | 5 | 0 |
| Light Diagnostics | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Bio-Rad Laboratories | 0 | 1 |
| Biochemical Diagnostic, Inc. | 1 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Cronus | 1 | 0 |
| Euro-Diagnostica AB | 1 | 0 |
| Immuno Concepts, N.A. , Ltd. | 1 | 0 |
| Immuno-Diagnostic Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2018 | K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts Immuno Concepts, N.A. , Ltd. | DBL |
| Apr 2, 1998 | K980312 | NOVA LITE ENDOMYSIAL Inova Diagnostics, Inc. | DBL |
| Feb 17, 1998 | K974169 | WIELISA ANTI-GBM TEST SYSTEM Wieslab AB | DBL |
| Oct 29, 1997 | K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT Euro-Diagnostica AB | DBL |
| May 23, 1997 | K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT Jay H. Geller | DBL |
| Nov 7, 1996 | K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT Shield Diagnostics, Ltd., GB | DBL |
| Apr 23, 1996 | K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT The Binding Site, Ltd. | DBL |
| Apr 10, 1996 | K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES Scimedx Corp. | DBL |
| Mar 6, 1995 | K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER Light Diagnostics | DBL |
| Mar 6, 1995 | K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER Light Diagnostics | DBL |
| Sep 26, 1994 | K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST Immco Diagnostics, Inc. | DBL |
| Jun 9, 1993 | K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST Immco Diagnostics, Inc. | DBL |
| Sep 10, 1991 | K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT Biochemical Diagnostic, Inc., SE | DBL |
| Jul 9, 1990 | K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT Medica Corp. | DBL |
| Mar 22, 1989 | K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) Immco Diagnostics, Inc. | DBL |
| Mar 22, 1989 | K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) Immco Diagnostics, Inc. | DBL |
| Oct 19, 1988 | K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) Immco Diagnostics, Inc. | DBL |
| Apr 20, 1987 | K871194 | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT Cronus | DBL |
| Jun 10, 1982 | K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC Immuno-Products Industries | DBL |
| Jan 26, 1982 | K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM Calbiochem-Behring Corp. | DBL |
| Aug 12, 1981 | K811261 | ANTI-SKIN ANTIBODY TEST SYSTEM Zeus Scientific, Inc. | DBL |
| Oct 10, 1980 | K801960 | ANTI-DS/N-DNA TEST KIT Immuno-Diagnostic Products, Inc. | DBL |
| Feb 22, 1980 | K792610 | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST Kallestad Laboratories, Inc. | DBL |
| Jan 16, 1980 | K791996 | MULTIPLE AUTO ANTIBODY TEST Meda Stat Diagnostics, Inc. | DBL |
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