FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIF TM
K Number: K970189
·
Decision May 21, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
27
Applicant Total
4
Review Days
120
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Basic Information
- Device Name
- FIF TM
- K Number
- K970189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Panbio, Inc.
- Date Received
- January 21, 1997
- Decision Date
- May 21, 1997
- Product Code
- KQJ
- 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 |
|---|---|---|---|
| KQJ | System, Fibrinogen Determination | FDA class 2 | Hematology |
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