FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIAS ANA TOTAL
K Number: K940641
·
Decision Mar 25, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
45
Review Days
39
Basic Information
- Device Name
- ELIAS ANA TOTAL
- K Number
- K940641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ELIAS USA, INC.
- Date Received
- February 14, 1994
- Decision Date
- March 25, 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 ELIAS USA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K964385 | ELIAS ANA-HEP-2 | Mar 6, 1997 | Substantially Equivalent |
| K963291 | VARELISA ANA (4) PROFILE | Sep 30, 1996 | Substantially Equivalent |
| K953873 | VARELISA HELICOBACTER PYLORI ANTIBODIES | Aug 30, 1996 | Substantially Equivalent |
| K951187 | VARELISA CARDIOLIPIN ABS SCREEN | Oct 2, 1995 | Substantially Equivalent |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | Apr 17, 1995 | Substantially Equivalent |
| K951205 | VARELISA ANA PROFILE | Apr 17, 1995 | Substantially Equivalent |
| K951207 | VARELISA HISTONE ANTIBODIES | Apr 17, 1995 | Substantially Equivalent |
| K944334 | VARELISA COMBINED DNA ANTIBODIES EIA | Apr 17, 1995 | Substantially Equivalent |
| K951186 | VARELISA ANA-4 SCREEN | Apr 17, 1995 | Substantially Equivalent |
| K950031 | VARELISA DSDNA ANTIBODIES (FARR VERSION) | Mar 10, 1995 | Substantially Equivalent |