FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBE, STAIN, RETICULOCYTE, LARC
K Number: K770792
·
Decision Jul 5, 1977
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
6
Applicant Total
111
Review Days
64
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Basic Information
- Device Name
- TUBE, STAIN, RETICULOCYTE, LARC
- K Number
- K770792
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- May 2, 1977
- Decision Date
- July 5, 1977
- Product Code
- KFC
- 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 |
|---|---|---|---|
| KFC | Methylene Blue, Tissue Stain | FDA class 1 | Hematology |
Similar 510(k) Clearances
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NEW METHYLENE BLUE N
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NEPHROLYTE
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