FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T/K (ATA/AMA) UNIVERSAL BIOPAK
K Number: K802308
·
Decision Dec 1, 1980
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
4
Review Days
69
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Basic Information
- Device Name
- T/K (ATA/AMA) UNIVERSAL BIOPAK
- K Number
- K802308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Bioware Products
- Date Received
- September 23, 1980
- Decision Date
- December 1, 1980
- Product Code
- DBM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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