FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THROMBO PLUS
K Number: K834527
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
1
Review Days
40
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Basic Information
- Device Name
- THROMBO PLUS
- K Number
- K834527
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- W. Sarstedt, Inc.
- Date Received
- December 21, 1983
- Decision Date
- January 30, 1984
- 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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