Pharmacia, Inc.: FDA filings under this applicant name
FDA lists 129 510(k) clearances under the applicant name “Pharmacia, Inc.” (first 1976, latest 1998), plus 1 PMA decision, across 48 product codes in 9 review panels. Median 510(k) review time under this name: 56 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 | 39 | 39 |
| DGC | Ige, Antigen, Antiserum, Control | 16 | 16 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 5 | 5 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 5 | 5 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 4 | 4 |
| FMF | Syringe, Piston | 3 | 3 |
| HDR | Cap, Cervical | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 | 3 |
| CHP | Radioimmunoassay, Estradiol | 2 | 2 |
Plus 38 more product codes.
Review panels
- Immunology (63)
- Clinical Chemistry (26)
- Microbiology (16)
- General Hospital (11)
- Obstetrics and Gynecology (4)
- General and Plastic Surgery (3)
- Ophthalmic (2)
- Anesthesiology (1)
- Clinical Toxicology (1)
Most recent Pharmacia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | DHB | 1998-02-09 | 82 |
| K972364 | UNICAP PHADIATOP | DHB | 1997-09-04 | 71 |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | DHB | 1997-07-03 | 30 |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | JQW | 1997-06-30 | 147 |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | DGC | 1997-04-23 | 189 |
| K962274 | UNICAP 100 | DHB | 1996-09-12 | 91 |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | DHB | 1996-01-30 | 645 |
| K954337 | GENOTROPIN MIXER | FMF | 1995-11-13 | 56 |
| K951025 | PISTON SYRINGE | FMF | 1995-10-19 | 227 |
| K952025 | ROBOCAP | JQW | 1995-07-26 | 86 |
119 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810042 | PMA | MODELS 011 & 011B IRIDOCAPSULAR IOLS | 1982-12-15 |
Recalls
openFDA lists no recalls under a recalling firm named Pharmacia, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pharmacia, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Deltec, Inc. (43 510(k)s)
- Pharmacia & Upjohn Co. (18 510(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, Inc.?
FDA lists 129 510(k) clearances under the applicant name “Pharmacia, Inc.” (first 1976, latest 1998), plus 1 PMA decision, across 48 product codes in 9 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmacia, Inc. is 56 days.
Which FDA product codes appear under Pharmacia, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 39); DGC (Ige, Antigen, Antiserum, Control, 16); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 5).
Next steps
- See all 129 Pharmacia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Pharmacia, 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.