Proteins Intl., Inc.: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “Proteins Intl., Inc.” (first 1992, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 51 | 51 |
| JSN | Culture Media, Propagating Transport | 2 | 2 |
| LIO | Device, Specimen Collection | 1 | 1 |
Review panels
- Pathology (51)
- Microbiology (3)
Most recent Proteins Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961756 | CYTOQUANT VIRAL TRANSPORT MEDIUM | JSN | 1996-05-17 | 11 |
| K961755 | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | JSN | 1996-05-17 | 11 |
| K930398 | 16 X 125 MM TEST TUBE, CATALOG #01-441 | KIR | 1993-03-24 | 57 |
| K930397 | 16 X 125 MM TEST TUBE, CATALOG | KIR | 1993-03-24 | 57 |
| K930396 | 16 X 125 MM TEST TUBE, CATALOG #01-291 | KIR | 1993-03-24 | 57 |
| K930395 | ONE DRAM SHELL VIAL, CATALOG #02-461 | KIR | 1993-03-24 | 57 |
| K930394 | 25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 | KIR | 1993-03-24 | 57 |
| K930393 | ONE DRAM SHELL VIAL, CATALOG #02-261 | KIR | 1993-03-24 | 57 |
| K930392 | 16 X 125 MM TEST TUBE, CATALOG #01-111 | KIR | 1993-03-24 | 57 |
| K930391 | 25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 | KIR | 1993-03-24 | 57 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Proteins Intl., 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 Proteins Intl., Inc.?
FDA lists 54 510(k) clearances under the applicant name “Proteins Intl., Inc.” (first 1992, latest 1996), across 3 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 Proteins Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Proteins Intl., Inc. is 56 days.
Which FDA product codes appear under Proteins Intl., Inc.?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 51); JSN (Culture Media, Propagating Transport, 2); LIO (Device, Specimen Collection, 1).
Next steps
- See all 54 Proteins Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIR, Proteins Intl., 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.