Pharmacia Deutschland GmbH: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pharmacia Deutschland GmbH” (first 2002, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 4 | 4 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 | 1 |
Review panels
- Immunology (10)
Most recent Pharmacia Deutschland GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041043 | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 | MOB | 2004-07-02 | 71 |
| K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 | LJM | 2004-05-14 | 46 |
| K040811 | VARELISA SSDNA ANTIBODIES, MODEL 14896 | LRM | 2004-05-13 | 45 |
| K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 | MSV | 2004-05-11 | 81 |
| K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 | MSV | 2004-05-11 | 81 |
| K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | MSV | 2004-05-11 | 81 |
| K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 | MSV | 2004-05-11 | 81 |
| K020758 | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 | MID | 2002-05-02 | 56 |
| K020757 | VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 | MID | 2002-05-02 | 56 |
| K020752 | VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 | MID | 2002-05-02 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Pharmacia Deutschland GmbH.
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 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 Deutschland GmbH?
FDA lists 10 510(k) clearances under the applicant name “Pharmacia Deutschland GmbH” (first 2002, latest 2004), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pharmacia Deutschland GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmacia Deutschland GmbH is 64 days.
Which FDA product codes appear under Pharmacia Deutschland GmbH?
The most frequent FDA product codes under this applicant name are MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), 4); MID (System, Test, Anticardiolipin Immunological, 3); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 1).
Next steps
- See all 10 Pharmacia Deutschland GmbH clearances with predicates and recalls
- Run predicate analysis for product code MSV, Pharmacia Deutschland GmbH'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.