FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS-FIBRO
K Number: K842717
·
Decision Oct 17, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
296
Review Days
96
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Basic Information
- Device Name
- COBAS-FIBRO
- K Number
- K842717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- July 13, 1984
- Decision Date
- October 17, 1984
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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