FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-GENT QUANTICHROM THROMBIGEN I
K Number: K800725
·
Decision Jun 4, 1980
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
30
Applicant Total
857
Review Days
64
Basic Information
- Device Name
- A-GENT QUANTICHROM THROMBIGEN I
- K Number
- K800725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- April 1, 1980
- Decision Date
- June 4, 1980
- Product Code
- GGW
- 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 |
|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | FDA class 2 | Hematology |
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