FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNICAP GLIADIN IGA ASSAY
K Number: K982533
·
Decision Oct 22, 1998
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
18
Review Days
94
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Basic Information
- Device Name
- UNICAP GLIADIN IGA ASSAY
- K Number
- K982533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharmacia & Upjohn Co.
- Date Received
- July 20, 1998
- Decision Date
- October 22, 1998
- Product Code
- MST
- 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 |
|---|---|---|---|
| MST | Antibodies, Gliadin | FDA class 2 | Immunology |
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Other Clearances by Pharmacia & Upjohn Co.
| K Number | Device Name | ||
|---|---|---|---|
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | Nov 27, 2000 | Substantially Equivalent |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | Oct 31, 2000 | Substantially Equivalent |
| K000312 | VARELISA SM ANTIBODIES | Mar 17, 2000 | Substantially Equivalent |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | Feb 18, 2000 | Substantially Equivalent |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | Jan 5, 2000 | Substantially Equivalent |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | Dec 1, 1999 | Substantially Equivalent |
| K993589 | VARELISA RNP ANTIBODIES | Nov 26, 1999 | Substantially Equivalent |
| K993109 | VARELISA RECOMBI ANA PROFILE | Nov 12, 1999 | Substantially Equivalent |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | Nov 12, 1999 | Substantially Equivalent |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Jul 28, 1999 | Substantially Equivalent |