FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABS CADKIT
K Number: K910636
·
Decision Apr 29, 1991
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
4
Review Days
75
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Basic Information
- Device Name
- ABS CADKIT
- K Number
- K910636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Panbio, Inc.
- Date Received
- February 13, 1991
- Decision Date
- April 29, 1991
- Product Code
- GIS
- 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 |
|---|---|---|---|
| GIS | Test, Fibrinogen | FDA class 2 | Hematology |
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