Cis Radiopharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Cis Radiopharmaceuticals, Inc.” (first 1976, latest 1979), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| IWA | Source, Wire, Iridium, Radioactive | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 | 1 |
| LEY | Set, Oral Administration | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Immunology (2)
- General Hospital (1)
- Radiology (1)
Most recent Cis Radiopharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791860 | FERRITIN RIA KIT | DBF | 1979-12-06 | 78 |
| K792063 | FOLLICLE STIMULATING HORMONE (FSH) KIT | CGJ | 1979-11-20 | 36 |
| K791202 | RIA KIT FOR TRYPSIN | JNO | 1979-11-05 | 130 |
| K792000 | LUTEINIZING HORMONE (LH) RIA | CEP | 1979-10-30 | 25 |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | 1979-07-24 | 48 |
| K790003 | RIA KIT, PROLACTIN | CFT | 1979-03-12 | 69 |
| K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT | DDR | 1978-06-22 | 8 |
| K771878 | IRIDIUM 192 WIRES & PINS | IWA | 1977-10-27 | 23 |
| K760251 | SET, ORAL ADMINISTRATION | LEY | 1976-09-15 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Cis Radiopharmaceuticals, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cis Radiopharmaceuticals, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Cis Radiopharmaceuticals, Inc.” (first 1976, latest 1979), across 9 product codes in 4 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 Cis Radiopharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cis Radiopharmaceuticals, Inc. is 48 days.
Which FDA product codes appear under Cis Radiopharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 1); CFT (Radioimmunoassay, Prolactin (Lactogen), 1); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 1).
Next steps
- See all 9 Cis Radiopharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Cis Radiopharmaceuticals, 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.