FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FETAL BOVINE SERUM
K Number: K800781
·
Decision Apr 21, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
44
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- FETAL BOVINE SERUM
- K Number
- K800781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2800
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biolabs, Inc.
- Date Received
- April 8, 1980
- Decision Date
- April 21, 1980
- Product Code
- KIS
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIS | Sera, Animal And Human | FDA class 1 | Hematology |
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