FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIFY(R) REFERENCE PLASMA
K Number: K881348
·
Decision May 2, 1988
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
98
Applicant Total
130
Review Days
33
Basic Information
- Device Name
- VERIFY(R) REFERENCE PLASMA
- K Number
- K881348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ORGANON TEKNIKA CORP.
- Date Received
- March 30, 1988
- Decision Date
- May 2, 1988
- 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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