FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MTS Plazomicin 0.016-256 µg/mL
K Number: K181708
·
Decision Jul 31, 2018
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
433
Applicant Total
22
Review Days
33
Basic Information
- Device Name
- MTS Plazomicin 0.016-256 µg/mL
- K Number
- K181708
- 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
- June 28, 2018
- Decision Date
- July 31, 2018
- 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 |
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Other Clearances by Liofilchem s. r. l.
| K Number | Device Name | ||
|---|---|---|---|
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Jan 30, 2025 | Substantially Equivalent |
| 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 |