FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE CULTURE FLASK
K Number: K864021
·
Decision Oct 29, 1986
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
12
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- TISSUE CULTURE FLASK
- K Number
- K864021
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Fenwal Laboratories
- Date Received
- October 15, 1986
- Decision Date
- October 29, 1986
- 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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