Company ยท US
Pharmacia & Upjohn Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2000. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 6 |
| JZO | System, Test, Thyroid Autoantibody | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| MST | Antibodies, Gliadin | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2000 | K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, Pharmacia & Upjohn Co. | JZO |
| Oct 31, 2000 | K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 Pharmacia & Upjohn Co. | MSS |
| Mar 17, 2000 | K000312 | VARELISA SM ANTIBODIES Pharmacia & Upjohn Co. | LKP |
| Feb 18, 2000 | K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 Pharmacia & Upjohn Co. | DHB |
| Jan 5, 2000 | K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 Pharmacia & Upjohn Co. | JZO |
| Dec 1, 1999 | K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F Pharmacia & Upjohn Co. | DHB |
| Nov 26, 1999 | K993589 | VARELISA RNP ANTIBODIES Pharmacia & Upjohn Co. | LKO |
| Nov 12, 1999 | K993109 | VARELISA RECOMBI ANA PROFILE Pharmacia & Upjohn Co. | LJM |
| Nov 12, 1999 | K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 Pharmacia & Upjohn Co. | LJM |
| Jul 28, 1999 | K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 Pharmacia & Upjohn Co. | DGC |
| May 14, 1999 | K991048 | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 Pharmacia & Upjohn Co. | DHB |
| Oct 22, 1998 | K982701 | UNICAP GLIADIN IGG ASSAY Pharmacia & Upjohn Co. | MST |
| Oct 22, 1998 | K982533 | UNICAP GLIADIN IGA ASSAY Pharmacia & Upjohn Co. | MST |
| Sep 15, 1998 | K982343 | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 Pharmacia & Upjohn Co. | DHB |
| Jul 7, 1998 | K981930 | UNICAP THYROID PEROXIDASE IGG Pharmacia & Upjohn Co. | JZO |
| Jul 7, 1998 | K981559 | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY Pharmacia & Upjohn Co. | JZO |
| Feb 9, 1998 | K974580 | ALLERGEN IMMUNOCAP F256,F245,F207,F202 Pharmacia & Upjohn Co. | DHB |
| Dec 23, 1996 | K962976 | PHARMACIA CAP SYSTEM RAST FEIA Pharmacia & Upjohn Co. | DHB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||