FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
K Number: K983244
·
Decision Nov 30, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
56
Review Days
75
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Basic Information
- Device Name
- SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
- K Number
- K983244
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trek Diagnostic Systems, Inc.
- Date Received
- September 16, 1998
- Decision Date
- November 30, 1998
- Product Code
- JTW
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | 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 |