FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORFLOXACIN SUSCEPTIBILITY POWDER
K Number: K864442
·
Decision Dec 11, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
13
Applicant Total
4
Review Days
29
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Basic Information
- Device Name
- NORFLOXACIN SUSCEPTIBILITY POWDER
- K Number
- K864442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Merck, Sharp & Dohme
- Date Received
- November 12, 1986
- Decision Date
- December 11, 1986
- Product Code
- JTT
- 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 |
|---|---|---|---|
| JTT | Susceptibility Test Powders, Antimicrobial | FDA class 2 | Microbiology |
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