FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
LUCOR CONFIRMATORY REAGENT
K Number: K922156
·
Decision Apr 6, 1993
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
15
Applicant Total
4
Review Days
334
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Basic Information
- Device Name
- LUCOR CONFIRMATORY REAGENT
- K Number
- K922156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8950
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gradipore , Ltd.
- Date Received
- May 7, 1992
- Decision Date
- April 6, 1993
- 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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