FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYSING REAGENT
K Number: K832182
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
5
Review Days
36
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Basic Information
- Device Name
- LYSING REAGENT
- K Number
- K832182
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Omega Medical Diagnostics
- Date Received
- July 7, 1983
- Decision Date
- August 12, 1983
- Product Code
- GGK
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | Hematology |
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