Trek Diagnostic Systems
FDA Regulatory Profile
Trek Diagnostic Systems appears in FDA public data with 1 recall, 68 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2323-2012, Class III) was initiated on Jul 23, 2012. Its most recent 510(k) clearance was granted on Jan 31, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 68
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2323-2012 | Class III | VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD wi | Jul 23, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Jan 31, 2014 |
| K112276 | VIZION | Nov 16, 2011 |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | Nov 8, 2011 |
| K110583 | SENSITITRE OPTIREAD | Sep 22, 2011 |
| K103532 | AUTOREADER 2 | Aug 26, 2011 |
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18- | Aug 18, 2011 |
| K103456 | THE SENSITITRE AIM | Jun 22, 2011 |
| K110331 | SENSITITRE AIM (TM) | Apr 27, 2011 |
| K093741 | SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES | Feb 25, 2010 |
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | Feb 17, 2010 |
| K092445 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Dec 16, 2009 |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Jun 4, 2009 |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | Mar 24, 2009 |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Mar 6, 2009 |
| K081520 | SENSITITRE VIZION | Oct 24, 2008 |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | Mar 20, 2008 |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | Mar 13, 2008 |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Jan 22, 2008 |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | Dec 20, 2006 |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 9, 2006 |