FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION REFERENCE PLASMA, NORMAL
K Number: K905203
·
Decision Dec 28, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
19
Applicant Total
57
Review Days
38
Basic Information
- Device Name
- COAGULATION REFERENCE PLASMA, NORMAL
- K Number
- K905203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- Date Received
- November 20, 1990
- Decision Date
- December 28, 1990
- Product Code
- GIZ
- 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 |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
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