FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
K Number: K953498
·
Decision Sep 8, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
- K Number
- K953498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunotech, Inc.
- Date Received
- July 26, 1995
- Decision Date
- September 8, 1995
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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