FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION REFERENCE PLASMA, ABNORMAL
K Number: K904073
·
Decision Oct 22, 1990
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
36
Review Days
47
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Basic Information
- Device Name
- COAGULATION REFERENCE PLASMA, ABNORMAL
- K Number
- K904073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- September 5, 1990
- Decision Date
- October 22, 1990
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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