FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRANSETTE SYSTEM/COLLECTION & TRANSP
K Number: K802563
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- TRANSETTE SYSTEM/COLLECTION & TRANSP
- K Number
- K802563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Inolex Corp./Div of Biomedical
- Date Received
- October 16, 1980
- Decision Date
- October 31, 1980
- Product Code
- JTW
- 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 |
|---|---|---|---|
| JTW | System, Transport, Aerobic | FDA class 1 | Microbiology |
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Other Clearances by Inolex Corp./Div of Biomedical
| K Number | Device Name | ||
|---|---|---|---|
| K771703 | ENTERIC 20 | Oct 4, 1977 | Substantially Equivalent |