FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNELISA PARIETAL CELL ANTIBODIES
K Number: K930422
·
Decision Aug 3, 1993
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
54
Review Days
189
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Basic Information
- Device Name
- SYNELISA PARIETAL CELL ANTIBODIES
- K Number
- K930422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5110
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Elias U.S.A., Inc.
- Date Received
- January 26, 1993
- Decision Date
- August 3, 1993
- Product Code
- DBJ
- 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 |
|---|---|---|---|
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DBJ), ordered by most recent decision date.
View allOther Clearances by Elias U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K953873 | VARELISA HELICOBACTER PYLORI ANTIBODIES | Aug 30, 1996 | Substantially Equivalent |
| K953586 | VARELISA PR3-ANCA | Jan 26, 1996 | Substantially Equivalent |
| K953587 | VARELISA MPO-ANCA | Jan 26, 1996 | Substantially Equivalent |
| K951187 | VARELISA CARDIOLIPIN ABS SCREEN | Oct 2, 1995 | Substantially Equivalent |
| K951205 | VARELISA ANA PROFILE | Apr 17, 1995 | Substantially Equivalent |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | 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 |