FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIQUID THROMBOPLASTIN REAGENT
K Number: K830331
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
124
Applicant Total
280
Review Days
63
Basic Information
- Device Name
- LIQUID THROMBOPLASTIN REAGENT
- K Number
- K830331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- HELENA LABORATORIES
- Date Received
- February 1, 1983
- Decision Date
- April 5, 1983
- Product Code
- GJS
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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