Pharmacia & Upjohn Co.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Pharmacia & Upjohn Co.” (first 1996, latest 2000), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 6 | 6 |
| JZO | System, Test, Thyroid Autoantibody | 4 | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
Review panels
- Immunology (17)
- Ophthalmic (1)
Most recent Pharmacia & Upjohn Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | JZO | 2000-11-27 | 25 |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | MSS | 2000-10-31 | 75 |
| K000312 | VARELISA SM ANTIBODIES | LKP | 2000-03-17 | 45 |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | DHB | 2000-02-18 | 31 |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | JZO | 2000-01-05 | 75 |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | DHB | 1999-12-01 | 54 |
| K993589 | VARELISA RNP ANTIBODIES | LKO | 1999-11-26 | 35 |
| K993109 | VARELISA RECOMBI ANA PROFILE | LJM | 1999-11-12 | 56 |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | LJM | 1999-11-12 | 56 |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | DGC | 1999-07-28 | 49 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pharmacia & Upjohn Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pharmacia, Inc. (129 510(k)s)
- Pharmacia Deltec, Inc. (43 510(k)s)
- Pharmacia Deutschland GmbH (10 510(k)s)
- Pharmacia Diagnostics, Inc. (7 510(k)s)
- Pharmacia Diagnostics AB (2 510(k)s)
- Pharmacia Eni Diagnostics, Inc. (2 510(k)s)
- Pharmacia Diagnostics GmbH & Co. KG (1 510(k)s)
- Pharmacia Fine Chemicals (1 510(k)s)
- Pharmacia Hepar, Inc. (1 510(k)s)
- Pharmacia Iovision, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharmacia & Upjohn Co.?
FDA lists 18 510(k) clearances under the applicant name “Pharmacia & Upjohn Co.” (first 1996, latest 2000), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pharmacia & Upjohn Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmacia & Upjohn Co. is 60 days.
Which FDA product codes appear under Pharmacia & Upjohn Co.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 6); JZO (System, Test, Thyroid Autoantibody, 4); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 2).
Next steps
- See all 18 Pharmacia & Upjohn Co. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Pharmacia & Upjohn Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.