Hybritech, Inc.: FDA filings under this applicant name
FDA lists 63 510(k) clearances under the applicant name “Hybritech, Inc.” (first 1981, latest 1997), across 22 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.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 14 | 14 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 5 | 5 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 4 | 4 |
| DGC | Ige, Antigen, Antiserum, Control | 4 | 4 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 4 | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 3 | 3 |
| DBF | Ferritin, Antigen, Antiserum, Control | 3 | 3 |
Plus 12 more product codes.
Review panels
- Clinical Chemistry (50)
- Immunology (8)
- Microbiology (4)
- Hematology (1)
Most recent Hybritech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | CIN | 1997-09-11 | 57 |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | CIN | 1996-08-19 | 118 |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | CIN | 1994-01-11 | 328 |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | JJX | 1993-02-17 | 254 |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | JFH | 1992-07-30 | 108 |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | JJX | 1992-07-17 | 123 |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | JJX | 1992-07-17 | 162 |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | JHY | 1992-06-09 | 56 |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | JJX | 1991-08-28 | 86 |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | GTZ | 1991-07-24 | 114 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hybritech, 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 Hybritech, Inc.?
FDA lists 63 510(k) clearances under the applicant name “Hybritech, Inc.” (first 1981, latest 1997), across 22 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 Hybritech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hybritech, Inc. is 48 days.
Which FDA product codes appear under Hybritech, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 14); JHY (Colorimetric Method, Cpk Or Isoenzymes, 5); CFT (Radioimmunoassay, Prolactin (Lactogen), 4).
Next steps
- See all 63 Hybritech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Hybritech, 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.