Cyberfluor, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Cyberfluor, Inc.” (first 1987, latest 1992), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 62 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 | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DFL | Igm, Ferritin, Antigen, Antiserum, Control | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (14)
- Immunology (1)
- Microbiology (1)
- Clinical Toxicology (1)
Most recent Cyberfluor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923410 | FIAGEN PROGESTERONE | JLS | 1992-12-03 | 146 |
| K905656 | FLAGEN TRIIODOTHYRONINE (T3) ASSAY | CDP | 1991-01-23 | 37 |
| K904539 | FLAGEN TM FREE T4 | CEC | 1990-11-30 | 57 |
| K900621 | FIAGEN(TM) HLH.S | CEP | 1990-03-01 | 21 |
| K895186 | FIAGEN T3 UPTAKE CATALOGUE #101-402 | KHQ | 1989-11-08 | 89 |
| K895396 | CYBERFLUOR FIAGEN TSH | JLW | 1989-10-31 | 60 |
| K884708 | FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT | CGJ | 1989-01-17 | 69 |
| K884707 | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | LCS | 1989-01-17 | 69 |
| K884201 | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | CEE | 1988-12-14 | 69 |
| K883182 | FIAGEN RUBELLA IGG | LFX | 1988-10-31 | 95 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cyberfluor, 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 Cyberfluor, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Cyberfluor, Inc.” (first 1987, latest 1992), across 15 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 Cyberfluor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cyberfluor, Inc. is 62 days.
Which FDA product codes appear under Cyberfluor, Inc.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 2); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 17 Cyberfluor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Cyberfluor, 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.