Pharmacia Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Pharmacia Diagnostics, Inc.” (first 1990, latest 1992), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 1 |
| LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 1 | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 |
Review panels
- Microbiology (6)
- Clinical Chemistry (1)
Most recent Pharmacia Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921011 | PHARMACIA CMV IGM ELISA | LFZ | 1992-07-27 | 146 |
| K920702 | TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO | LGD | 1992-07-08 | 141 |
| K915348 | EBV-VCA IGM ELISA | LJN | 1992-02-14 | 80 |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | LFY | 1992-01-27 | 140 |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | JLX | 1991-06-25 | 49 |
| K902793 | RUBELLA IGG | LFX | 1990-07-31 | 35 |
| K902792 | TOXOPLASMA GONDII IGG | LGD | 1990-07-24 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Pharmacia Diagnostics, Inc..
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 & Upjohn Co. (18 510(k)s)
- Pharmacia Deutschland GmbH (10 510(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 Diagnostics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Pharmacia Diagnostics, Inc.” (first 1990, latest 1992), across 6 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 Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmacia Diagnostics, Inc. is 80 days.
Which FDA product codes appear under Pharmacia Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 2); JLX (Radioimmunoassay, 17-Hydroxyprogesterone, 1); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 1).
Next steps
- See all 7 Pharmacia Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LGD, Pharmacia Diagnostics, Inc.'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.