FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBOPLASTIN-LI REAGENT
K Number: K951820
·
Decision Oct 20, 1995
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
124
Applicant Total
280
Review Days
183
Basic Information
- Device Name
- THROMBOPLASTIN-LI REAGENT
- K Number
- K951820
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HELENA LABORATORIES
- Date Received
- April 20, 1995
- Decision Date
- October 20, 1995
- 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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