FDA 510(k) Applications Submitted by NORMAN JENKINS
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K990462 |
02/12/1999 |
IS H. PYLORI IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K961183 |
03/26/1996 |
CBI 7520 READER |
COLUMBIA BIOSCIENCE, INC. |
K991274 |
04/13/1999 |
MUMPS IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K981812 |
05/22/1998 |
EBV-VCA IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
K981829 |
05/22/1998 |
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
K981831 |
05/22/1998 |
IS EBV-EA-D IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
K962113 |
05/31/1996 |
ANTHOS PHACTS VERSION MICROPLATE READER |
COLUMBIA BIOSCIENCE, INC. |
K982348 |
07/06/1998 |
EBNA-1 IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K982350 |
07/06/1998 |
EA-D IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K982352 |
07/06/1998 |
VCA IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K983390 |
09/25/1998 |
IS-ANTI-MPO IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K983553 |
10/09/1998 |
ANTI-TG IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K983605 |
10/14/1998 |
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K983606 |
10/14/1998 |
IS BORRELIA BURGDORFERI IGM TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K983740 |
10/22/1998 |
IS-ANTI-PR3 IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
K984228 |
11/25/1998 |
IS ANTI-TPO IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
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