FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
K Number: K854724
·
Decision Dec 13, 1985
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
7
Applicant Total
1
Review Days
21
Basic Information
- Device Name
- CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
- K Number
- K854724
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- LIFETRAC, INC.
- Date Received
- November 22, 1985
- Decision Date
- December 13, 1985
- Product Code
- KIZ
- 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 |
|---|---|---|---|
| KIZ | Dish, Tissue Culture | FDA class 1 | Hematology |
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