FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOVINE THROMBIN, HUMAN THROMBIN
K Number: K841956
·
Decision Jul 19, 1984
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
19
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- BOVINE THROMBIN, HUMAN THROMBIN
- K Number
- K841956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Haemachem, Inc.
- Date Received
- May 14, 1984
- Decision Date
- July 19, 1984
- Product Code
- GJA
- 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 |
|---|---|---|---|
| GJA | Test, Thrombin Time | FDA class 2 | Hematology |
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