Hyclone Laboratories, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Hyclone Laboratories, Inc.” (first 1987, latest 1988), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| KIS | Sera, Animal And Human | 10 | 10 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 | 1 |
Review panels
- Pathology (11)
Most recent Hyclone Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884654 | ALPHACALF SERUM | KIT | 1988-11-30 | 23 |
| K880471 | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | KIS | 1988-04-04 | 61 |
| K880470 | BOVINE CALF SERUM CATALOG #A-2119 | KIS | 1988-04-01 | 58 |
| K870938 | FETAL BOVINE SERUM | KIS | 1987-03-31 | 22 |
| K870469 | DEFINED EQUINE SERUM #A-3311 | KIS | 1987-03-24 | 49 |
| K870468 | ADULT BOVINE SERUM | KIS | 1987-03-24 | 49 |
| K870467 | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | KIS | 1987-03-24 | 49 |
| K870466 | DEFINED CALF BOVINE SERUM #A-2111 | KIS | 1987-03-24 | 49 |
| K870465 | 6/40 FETAL BOVINE SERUM #A-1110 | KIS | 1987-03-24 | 49 |
| K870464 | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | KIS | 1987-03-24 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hyclone Laboratories, 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 Hyclone Laboratories, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Hyclone Laboratories, Inc.” (first 1987, latest 1988), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hyclone Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hyclone Laboratories, Inc. is 49 days.
Which FDA product codes appear under Hyclone Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KIS (Sera, Animal And Human, 10); KIT (Media And Components, Synthetic Cell And Tissue Culture, 1).
Next steps
- See all 11 Hyclone Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIS, Hyclone Laboratories, 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.