FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K Number: K010750
·
Decision Sep 7, 2001
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
16
Review Days
178
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Basic Information
- Device Name
- PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
- K Number
- K010750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher Diagnostics
- Date Received
- March 13, 2001
- Decision Date
- September 7, 2001
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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