FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
K Number: K132076
·
Decision Jan 10, 2014
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
15
Applicant Total
2
Review Days
191
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Basic Information
- Device Name
- REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
- K Number
- K132076
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 864.8950
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dsrv, Inc.
- Date Received
- July 3, 2013
- Decision Date
- January 10, 2014
- Product Code
- GIR
- 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 |
|---|---|---|---|
| GIR | Reagent, Russel Viper Venom | FDA class 1 | Hematology |
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Other Clearances by Dsrv, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Jan 10, 2014 | Substantially Equivalent |