Panels › Immunology › Product code MOB · Class 2
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation 866.5660
1510(k)s in 12 months (75 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MOB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 17, 1998 | K974167 | WIELISA PR-3 ANCA TEST SYSTEM Wieslab AB | MOB |
| Feb 17, 1998 | K974166 | WIELISA MPO ANCA TEST SYSTEM Wieslab AB | MOB |
| Feb 9, 1998 | K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS Immuno Concepts, Inc. | MOB |
| Feb 9, 1998 | K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM Immuno Concepts, Inc. | MOB |
| Nov 13, 1997 | K973824 | VIRGO PANCO KIT Hemagen Diagnostics, Inc. | MOB |
| Nov 13, 1997 | K973823 | PR 3 ANTIBODY KIT Hemagen Diagnostics, Inc. | MOB |
| Nov 13, 1997 | K973822 | VIRGO ANCA SCREEN KIT Hemagen Diagnostics, Inc. | MOB |
| Oct 29, 1997 | K971690 | IMMUNOSCAN PR3-ANCA Euro-Diagnostica AB | MOB |
| Oct 29, 1997 | K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT Euro-Diagnostica AB | MOB |
| May 21, 1997 | K965133 | ANCA COMBI DIAGNOSTIC TEST KIT The Binding Site, Ltd. | MOB |
| Apr 10, 1997 | K964449 | ANCA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. | MOB |
| Apr 10, 1997 | K964448 | PROTEINASE-3 IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | MOB |
| Apr 10, 1997 | K964446 | MYELOPEROXIDASE ELISA TEST SYSTEM Zeus Scientific, Inc. | MOB |
| Sep 30, 1996 | K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES Scimedx Corp. | MOB |
| Aug 19, 1996 | K961765 | MPO ELISA TEST SYSTEM Immunoprobe, Inc. | MOB |
| Aug 19, 1996 | K961764 | PR-3 ELISA TEST SYSTEM Immunoprobe, Inc. | MOB |
| Jul 10, 1996 | K961340 | NOVA LITE ANCA Inova Diagnostics, Inc. | MOB |
| Mar 19, 1996 | K955022 | QUANTA LITE MPO Inova Diagnostics, Inc. | MOB |
| Mar 19, 1996 | K955021 | QUANTA LITE PR3 Inova Diagnostics, Inc. | MOB |
| Mar 19, 1996 | K954105 | EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES Scimedx Corp. | MOB |
| Mar 19, 1996 | K954062 | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES Scimedx Corp. | MOB |
| Jan 26, 1996 | K953587 | VARELISA MPO-ANCA Elias U.S.A., Inc. | MOB |
| Jan 26, 1996 | K953586 | VARELISA PR3-ANCA Elias U.S.A., Inc. | MOB |
| Mar 6, 1995 | K943630 | DIASTAT ANTI-MPO (PANCA) KIT Shield Diagnostics, Ltd., GB | MOB |
| Mar 6, 1995 | K942813 | DIASTAT ANTI-PR3 (C-ANCA) KIT Shield Diagnostics, Ltd., GB | MOB |
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