FDA 510(k) Applications Submitted by ARK DIAGNOSTICS,INC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K101305 |
05/10/2010 |
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL |
ARK DIAGNOSTICS,INC |
| K101574 |
06/07/2010 |
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 |
ARK DIAGNOSTICS,INC |
| K091653 |
06/09/2009 |
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 |
ARK DIAGNOSTICS,INC |
| K091884 |
06/24/2009 |
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 |
ARK DIAGNOSTICS,INC |
| K083799 |
12/22/2008 |
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 |
ARK DIAGNOSTICS,INC |
| K111904 |
07/05/2011 |
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN |
ARK DIAGNOSTICS,INC |
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