Microgenics Corp
Microgenics Corp appears in FDA public data with 2 recalls, 107 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0513-2014, Class II) was initiated on Oct 16, 2013. Its most recent 510(k) clearance was granted on Aug 20, 2013.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 107
- Inspections
- 0
- Compliance Actions
- 0
Known Names
Microgenics Corporation, Microgenics
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0513-2014 | Class II | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product | Oct 16, 2013 |
| Z-2267-2013 | Class II | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, I | Jul 23, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY | Aug 20, 2013 |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Jul 11, 2013 |
| K123271 | ABBOTT PHENOBARBITAL ASSAY | Apr 26, 2013 |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Jun 29, 2011 |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Apr 8, 2011 |
| K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY | Apr 8, 2011 |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Apr 8, 2011 |
| K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY | Apr 8, 2011 |
| K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY | Apr 8, 2011 |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | Apr 8, 2011 |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | Apr 8, 2011 |
| K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS | Feb 11, 2011 |
| K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY | May 12, 2010 |
| K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5 | Sep 21, 2009 |
| K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES | Sep 18, 2009 |
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL | May 30, 2006 |
| K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS | Feb 3, 2006 |
| K051074 | MAS IMMUNOSUPPRESSANT CONTROLS | Jun 6, 2005 |
| K050206 | CEDIA TACROLIMUS ASSAY | Mar 15, 2005 |
| DEN040008 | CEDIA SIROLIMUS ASSAY | Jul 28, 2004 |