FDA 510(k) Applications Submitted by Eric S. Hoy
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180202 |
01/24/2018 |
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts |
Immuno Concepts, NA, Ltd. |
| K030775 |
03/11/2003 |
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM |
IMMUNO CONCEPTS, N.A., LTD |
| K972145 |
06/06/1997 |
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K992041 |
06/17/1999 |
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 |
IMMUNO CONCEPTS, INC. |
| K963275 |
08/20/1996 |
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K013283 |
10/02/2001 |
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 |
IMMUNO CONCEPTS, INC. |
| K013285 |
10/02/2001 |
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 |
IMMUNO CONCEPTS, INC. |
| K013432 |
10/15/2001 |
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G |
IMMUNO CONCEPTS, INC. |
| K983924 |
11/04/1998 |
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO |
IMMUNO CONCEPTS, INC. |
| K974463 |
11/26/1997 |
IMMUNO CONCEPTS ANCA TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K974478 |
11/26/1997 |
IMMUNO CONCEPTS ANCA TEST SYSTEMS |
IMMUNO CONCEPTS, INC. |
| K955602 |
12/08/1995 |
RELSIA SCL-70 ANTIBODY TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K955603 |
12/08/1995 |
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K955604 |
12/08/1995 |
RELISA SM/RNP ANTIBODY TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K955605 |
12/08/1995 |
RELISA JO-1 ANTIBODY TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
| K160265 |
02/02/2016 |
Image Navigator by Immuno Concepts |
Immuno Concepts, NA, Ltd. |
| K203599 |
12/09/2020 |
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System |
Immuno Concepts N.A., Ltd. |
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