FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEPHROLYTE
K Number: K831502
·
Decision Jul 18, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
6
Applicant Total
1
Review Days
68
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Basic Information
- Device Name
- NEPHROLYTE
- K Number
- K831502
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Flaitron Laboratories, Inc.
- Date Received
- May 11, 1983
- Decision Date
- July 18, 1983
- Product Code
- KFC
- 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 |
|---|---|---|---|
| KFC | Methylene Blue, Tissue Stain | FDA class 1 | Hematology |
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