FDA 510(k) Applications Submitted by LISA CHARTER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100144 |
01/19/2010 |
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS |
MICROGENICS CORP. |
| K050206 |
01/28/2005 |
CEDIA TACROLIMUS ASSAY |
MICROGENICS CORP. |
| K110616 |
03/03/2011 |
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO |
MICROGENICS CORP. |
| K110738 |
03/17/2011 |
THERMO SCIENTIFIC MAS OMNI-CORE |
Microgenics Corporation |
| K090810 |
03/25/2009 |
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES |
MICROGENICS CORP. |
| K051074 |
04/27/2005 |
MAS IMMUNOSUPPRESSANT CONTROLS |
MICROGENICS CORP. |
| K101742 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY |
MICROGENICS CORP. |
| K101744 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY |
MICROGENICS CORP. |
| K101745 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY |
MICROGENICS CORP. |
| K101746 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY |
MICROGENICS CORP. |
| K101752 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS |
MICROGENICS CORP. |
| K101753 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY |
MICROGENICS CORP. |
| K101754 |
06/22/2010 |
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY |
MICROGENICS CORP. |
| DEN160026 |
06/28/2016 |
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia |
23andMe, Inc. |
| K092051 |
07/07/2009 |
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 |
MICROGENICS CORP. |
| DEN170046 |
09/05/2017 |
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) |
23andMe, Inc. |
| K092749 |
09/08/2009 |
MAS AND MINI-TROL PTH CONTROL |
Microgenics Corporation |
| K103656 |
12/15/2010 |
THERMO SCIENTIFIC MAS R DOA TOTAL |
Microgenics Corporation |
| K193492 |
12/17/2019 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
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