FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN VITRO 2.5X ROLLER BOTTLE
K Number: K873137
·
Decision Aug 24, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- IN VITRO 2.5X ROLLER BOTTLE
- K Number
- K873137
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- In Vitro Scientific Products
- Date Received
- August 10, 1987
- Decision Date
- August 24, 1987
- Product Code
- KJC
- 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 |
|---|---|---|---|
| KJC | Bottle, Roller, Tissue Culture | FDA class 1 | Hematology |
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