FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VERSATREK
K Number: K032306
·
Decision Aug 22, 2003
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
56
Review Days
28
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Basic Information
- Device Name
- VERSATREK
- K Number
- K032306
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trek Diagnostic Systems, Inc.
- Date Received
- July 25, 2003
- Decision Date
- August 22, 2003
- Product Code
- MDB
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
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Other Clearances by Trek Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093865 | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES | Feb 17, 2010 | Substantially Equivalent |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Jun 4, 2009 | Substantially Equivalent |
| K083606 | SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES | Mar 24, 2009 | Substantially Equivalent |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Mar 6, 2009 | Substantially Equivalent |
| K081520 | SENSITITRE VIZION | Oct 24, 2008 | Substantially Equivalent |
| K073653 | SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE | Mar 20, 2008 | Substantially Equivalent |
| K073558 | SENSITITRE 18-24 SUSCEPTIBILITY PLATE | Mar 13, 2008 | Substantially Equivalent |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | Jan 22, 2008 | Substantially Equivalent |
| K062841 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES | Dec 20, 2006 | Substantially Equivalent |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 9, 2006 | Substantially Equivalent |