FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TODD HEWITT W/CNA (LIM BROTH)
K Number: K871447
·
Decision May 13, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
25
Applicant Total
137
Review Days
30
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Basic Information
- Device Name
- TODD HEWITT W/CNA (LIM BROTH)
- K Number
- K871447
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- April 13, 1987
- Decision Date
- May 13, 1987
- Product Code
- JSD
- 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 |
|---|---|---|---|
| JSD | Culture Media, Selective Broth | FDA class 1 | Microbiology |
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