FDA 510(k) Applications Submitted by ALAN MADERAZO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K181663 |
06/25/2018 |
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel |
GenMark Diagnostics, Incorporated |
| K022874 |
07/26/2002 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K032554 |
08/19/2003 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K152612 |
09/14/2015 |
eSensor Warfarin Sensitivity Saliva Test |
GENMARK DIAGNOSTICS, INCORPORATED |
| K182619 |
09/24/2018 |
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
GenMark Diagnostics, Incorporated |
| K213236 |
09/30/2021 |
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel |
GenMark Diagnostics, Incorporated |
| K043072 |
11/08/2004 |
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS |
GEN-PROBE, INC. |
| K043144 |
11/15/2004 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE |
GEN-PROBE, INC. |
| K043224 |
11/22/2004 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
| K163636 |
12/22/2016 |
ePlex Respiratory Pathogen Panel |
GENMARK DIAGNOSTICS, INCORPORATED |
| K163652 |
12/23/2016 |
ePlex Instrument |
GenMark Diagnostics, Incorporated |
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