FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MTS Ceftobiprole 0.002-32 µg/mL
K Number: K243202
·
Decision Jan 30, 2025
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
433
Applicant Total
22
Review Days
121
Basic Information
- Device Name
- MTS Ceftobiprole 0.002-32 µg/mL
- K Number
- K243202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Liofilchem s. r. l.
- Date Received
- October 1, 2024
- Decision Date
- January 30, 2025
- 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.
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
FDA 510(k)
FDA Class 2
·Microbiology
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Liofilchem s. r. l.
| K Number | Device Name | ||
|---|---|---|---|
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | Mar 20, 2020 | Substantially Equivalent |
| K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | Oct 31, 2019 | Substantially Equivalent |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | Aug 23, 2019 | Substantially Equivalent |
| K190914 | MTS Doxycycline 0.016 - 256 µg/mL | May 29, 2019 | Substantially Equivalent |
| K190252 | MTS Gentamicin 0.016 - 256 µg/mL | Mar 22, 2019 | Substantially Equivalent |
| K183527 | MTS Ciprofloxacin 0.002 - 32 µg/mL | Mar 19, 2019 | Substantially Equivalent |
| K183115 | MTS Levofloxacin 0.002 - 32 µg/mL | Dec 20, 2018 | Substantially Equivalent |
| K182922 | MTS Omadacycline 0.002-32 µg/mL | Dec 14, 2018 | Substantially Equivalent |
| K182557 | MTS Eravacycline 0.002 - 32 µg/mL | Nov 2, 2018 | Substantially Equivalent |
| K181889 | MTS Penicillin 0.002- 32 µg/mL | Sep 13, 2018 | Substantially Equivalent |