The Upjohn Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “The Upjohn Co.” (first 1976, latest 1990), plus 3 PMA decisions, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JTT | Susceptibility Test Powders, Antimicrobial | 3 | 0 |
| LOP | Solution, Antimicrobial | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHT | Electrophoretic Method, Catecholamines | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
Review panels
- Microbiology (5)
- Clinical Chemistry (4)
Most recent The Upjohn Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902004 | TROBICIN SUSCEPTIBILITY POWDER | LOP | 1990-05-15 | 39 |
| K900455 | ZEFAZONE SUSCEPTIBILITY POWDER | LOP | 1990-02-09 | 10 |
| K810853 | CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT | CGS | 1981-05-29 | 60 |
| K782009 | RIA KIT, PROGESTERONE | JLS | 1979-03-02 | 91 |
| K780792 | TESTOSTERONE RADIOIMMUNOASSAY KIT 125I | CDZ | 1978-06-13 | 29 |
| K760920 | CAT-A-KIT | CHT | 1976-11-09 | 12 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50407 | PMA | STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE | 1971-06-30 |
| N50163 | PMA | STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN) | 1970-07-29 |
| N61034 | PMA | LINCOCIN SUSCEPTIBILITY PWD | 1968-10-09 |
Recalls
openFDA lists no recalls under a recalling firm named The 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Upjohn Co.?
FDA lists 6 510(k) clearances under the applicant name “The Upjohn Co.” (first 1976, latest 1990), plus 3 PMA decisions, 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 The Upjohn Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Upjohn Co. is 34 days.
Which FDA product codes appear under The Upjohn Co.?
The most frequent FDA product codes under this applicant name are JTT (Susceptibility Test Powders, Antimicrobial, 3); LOP (Solution, Antimicrobial, 2); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1).
Next steps
- See all 6 The Upjohn Co. clearances with predicates and recalls
- Run predicate analysis for product code JTT, The 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.