FDA 510(k) Applications Submitted by WILLIAM L BOTELER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961221 |
03/20/1996 |
PYLORI IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K971393 |
04/09/1997 |
MYCOPLASMA IGG ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
| K961765 |
05/07/1996 |
MPO ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
| K972406 |
06/26/1997 |
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
| K962558 |
07/01/1996 |
CHLAMYDIA IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K973123 |
08/20/1997 |
EA-D IGG ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
| K974166 |
11/05/1997 |
WIELISA MPO ANCA TEST SYSTEM |
WIESLAB AB |
| K974167 |
11/05/1997 |
WIELISA PR-3 ANCA TEST SYSTEM |
WIESLAB AB |
| K974169 |
11/05/1997 |
WIELISA ANTI-GBM TEST SYSTEM |
WIESLAB AB |
| K963318 |
08/23/1996 |
LEGIONELLA IGG/IGM ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K980912 |
03/10/1998 |
VCA IGG ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
| K961764 |
05/07/1996 |
PR-3 ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
| K981750 |
05/18/1998 |
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
| K051455 |
06/02/2005 |
WIESLAB CAP MPO-ANCA |
EURODIAGNOSTICA |
| K051458 |
06/02/2005 |
WIESLAB CAP PR-3 ANCA |
EURODIAGNOSTICA |
| K052133 |
08/05/2005 |
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM |
EURODIAGNOSTICA |
| K965129 |
12/23/1996 |
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
| K965131 |
12/23/1996 |
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
| K980596 |
02/17/1998 |
VCA IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
| K980598 |
02/17/1998 |
EBNA-1 IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
| K981748 |
05/18/1998 |
WIELISA ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
| K963645 |
09/12/1996 |
HERPES GROUP IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
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