FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JUSTONE(TM)
K Number: K912846
·
Decision Aug 22, 1991
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
3
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JUSTONE(TM)
- K Number
- K912846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sensititre Microbiology A Div. of Radiometer
- Date Received
- June 12, 1991
- Decision Date
- August 22, 1991
- 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)
FDA 510(k)
FDA Class 2
·Microbiology
MTS Gepotidacin 0.016-256 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS Aztreonam-Avibactam 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 Colistin in the dilution range of 0.12-16 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
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
FDA 510(k)
FDA Class 2
·Microbiology
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology