FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
K Number: K062841
·
Decision Dec 20, 2006
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
56
Review Days
89
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Basic Information
- Device Name
- SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
- K Number
- K062841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trek Diagnostic Systems, Inc.
- Date Received
- September 22, 2006
- Decision Date
- December 20, 2006
- Product Code
- JWY
- 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWY), ordered by most recent decision date.
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
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MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
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·Microbiology
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 |
| K062839 | MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 9, 2006 | Substantially Equivalent |
| K062816 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | Nov 1, 2006 | Substantially Equivalent |