FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
LUPO-TEST REAGENT
K Number: K903037
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
15
Applicant Total
4
Review Days
159
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LUPO-TEST REAGENT
- K Number
- K903037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8950
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gradipore , Ltd.
- Date Received
- July 11, 1990
- Decision Date
- December 17, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIR), ordered by most recent decision date.
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
FDA 510(k)
FDA Class 1
·Hematology
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
FDA 510(k)
FDA Class 1
·Hematology
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
FDA 510(k)
FDA Class 1
·Hematology
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
FDA 510(k)
FDA Class 1
·Hematology
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
FDA 510(k)
FDA Class 1
·Hematology
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
FDA 510(k)
FDA Class 1
·Hematology