Cirrus Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cirrus Diagnostics, Inc.” (first 1991, latest 1992), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
Review panels
Most recent Cirrus Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921704 | IMMULITE(R) FSH | CGJ | 1992-06-09 | 60 |
| K920411 | IMMULITE HLH | CEP | 1992-03-11 | 40 |
| K914833 | IMMULITE DIGOXIN | DPO | 1991-11-22 | 28 |
| K911796 | IMMULITE(TM) HCG | DHA | 1991-06-20 | 59 |
| K910677 | IMMULITE(TM) T-UPTAKE | CEE | 1991-04-29 | 73 |
| K910261 | IMMULITE(TM) TOTAL T4 | KLI | 1991-04-16 | 84 |
| K905648 | CRP LIPID REAGENT TEST PACK | CHH | 1991-03-06 | 79 |
| K905214 | IMMULITE (TM) TOTAL T3 | CDP | 1991-02-01 | 73 |
| K905769 | IMMULITE HS-TSH | JLW | 1991-01-31 | 35 |
| K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | JJQ | 1991-01-11 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Cirrus 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.
- Cirrus Medical,Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cirrus Diagnostics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Cirrus Diagnostics, Inc.” (first 1991, latest 1992), across 10 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 Cirrus Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cirrus Diagnostics, Inc. is 60 days.
Which FDA product codes appear under Cirrus Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CEE (Radioimmunoassay, Thyroxine-Binding Globulin, 1); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 10 Cirrus Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Cirrus 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.