FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE SENSITITRE AIM
K Number: K103456
·
Decision Jun 22, 2011
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
6
Applicant Total
5
Review Days
210
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Basic Information
- Device Name
- THE SENSITITRE AIM
- K Number
- K103456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trek Diagnostic Systems
- Date Received
- November 24, 2010
- Decision Date
- June 22, 2011
- Product Code
- LIE
- 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 |
|---|---|---|---|
| LIE | Reagent/Device, Inoculum Calibration | FDA class 2 | Microbiology |
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Other Clearances by Trek Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Jan 31, 2014 | Substantially Equivalent |
| K112276 | VIZION | Nov 16, 2011 | Substantially Equivalent |
| K111615 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES | Nov 8, 2011 | Substantially Equivalent |
| K103532 | AUTOREADER 2 | Aug 26, 2011 | Substantially Equivalent |