FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K Number: K853441
·
Decision Aug 26, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
4
Review Days
13
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Basic Information
- Device Name
- FETAL BOVINE SERUM IN TRANSFER CONTAINER
- K Number
- K853441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Newport Biosystems, Inc.
- Date Received
- August 13, 1985
- Decision Date
- August 26, 1985
- Product Code
- KJA
- 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 |
|---|---|---|---|
| KJA | Flask, Tissue Culture | FDA class 1 | Hematology |
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