FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL
K Number: K802994
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL
- K Number
- K802994
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Sacks Farms Biological Products
- Date Received
- November 25, 1980
- Decision Date
- December 22, 1980
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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