FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RNP EIA TEST KIT
K Number: K935415
·
Decision May 2, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
9
Review Days
174
Basic Information
- Device Name
- RNP EIA TEST KIT
- K Number
- K935415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DAVID A. FUCCILLO, PH.D.
- Date Received
- November 9, 1993
- Decision Date
- May 2, 1994
- Product Code
- LJM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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Other Clearances by DAVID A. FUCCILLO, PH.D.
| K Number | Device Name | ||
|---|---|---|---|
| K935413 | ENA EIA TEST KIT | Jun 2, 1994 | Substantially Equivalent |
| K935417 | JO-1 EIA TEST KIT | May 5, 1994 | Substantially Equivalent |
| K935419 | LA EIA TEST KIT | May 5, 1994 | Substantially Equivalent |
| K935418 | SCL-70 EIA TEST KIT | May 5, 1994 | Substantially Equivalent |
| K940251 | MITOCHONDRIA EIA TEST KIT | May 3, 1994 | Substantially Equivalent |
| K940253 | HISTONE EIA TEST KIT | May 2, 1994 | Substantially Equivalent |
| K935416 | RO EIA TEST KIT | May 2, 1994 | Substantially Equivalent |
| K935414 | SM EIA TEST KIT | May 2, 1994 | Substantially Equivalent |