Pharmacia & Upjohn Company LLC
Kalamazoo, MI, US
PHARMACIA & UPJOHN COMPANY LLC appears in FDA device records in Kalamazoo, MI. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Pharmacia & Upjohn Company LLC between 1996 and 2000. The busiest year on record is 1998, with 6. The most recent is 2000, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1998 | 6 |
| 1999 | 6 |
| 2000 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | JZO | Substantially Equivalent | |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | MSS | Substantially Equivalent | |
| K000312 | VARELISA SM ANTIBODIES | LKP | Substantially Equivalent | |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | DHB | Substantially Equivalent | |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | JZO | Substantially Equivalent | |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | DHB | Substantially Equivalent | |
| K993589 | VARELISA RNP ANTIBODIES | LKO | Substantially Equivalent | |
| K993109 | VARELISA RECOMBI ANA PROFILE | LJM | Substantially Equivalent | |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | LJM | Substantially Equivalent | |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | DGC | Substantially Equivalent | |
| K991048 | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 | DHB | Substantially Equivalent | |
| K982701 | UNICAP GLIADIN IGG ASSAY | MST | Substantially Equivalent | |
| K982533 | UNICAP GLIADIN IGA ASSAY | MST | Substantially Equivalent | |
| K982343 | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 | DHB | Substantially Equivalent | |
| K981930 | UNICAP THYROID PEROXIDASE IGG | JZO | Substantially Equivalent | |
| K981559 | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY | JZO | Substantially Equivalent | |
| K974580 | ALLERGEN IMMUNOCAP F256,F245,F207,F202 | DHB | Substantially Equivalent | |
| K962976 | PHARMACIA CAP SYSTEM RAST FEIA | DHB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1810189 | 1810189 | PHARMACIA & UPJOHN COMPANY LLC | 7000 PORTAGE RD., KALAMAZOO, MI 49001 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMFAgent, Absorbable Hemostatic, Collagen Based
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- MSTAntibodies, Gliadin
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- MSSFolders And Injectors, Intraocular Lens (Iol)
- DGCIge, Antigen, Antiserum, Control
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- JZOSystem, Test, Thyroid Autoantibody
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain