Tissue Culture Innovations: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tissue Culture Innovations” (first 1986, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 9 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 5 | 5 |
| KIP | Formulations, Balanced Salt Solutions | 1 | 1 |
Review panels
- Pathology (6)
Most recent Tissue Culture Innovations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860788 | HAM'S F-12 W/GLUTAMINE & NAHCO3 | KIT | 1986-03-12 | 9 |
| K860787 | DULBECCO'S MEM | KIT | 1986-03-12 | 9 |
| K860786 | RPMI 1640 HEPES | KIT | 1986-03-12 | 9 |
| K860785 | HAM'S F-12 W/NAHCO3 | KIT | 1986-03-12 | 9 |
| K860784 | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | KIP | 1986-03-12 | 9 |
| K860783 | MICRO CARRIER | KIT | 1986-03-12 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Tissue Culture Innovations.
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.
- Tissue Technologies, Inc. (9 510(k)s)
- Tissue Science Laboratories, Plc (6 510(k)s)
- Tissue Regeneration Technologies, LLC (5 510(k)s)
- Tissue Technologies Holdings, LLC (2 510(k)s)
- Tissue Culture Biologicals (1 510(k)s)
- Tissue Culture Biotec, Inc. (1 510(k)s)
- Tissue Differentiation Intelligence, LLC (1 510(k)s)
- Tissue Medical Lasers, Inc. (1 510(k)s)
- Tissue Regeneration Systems, Inc. (1 510(k)s)
- Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (1 510(k)s)
- Tissue Regenix Group Plc (1 510(k)s)
- Tissue Repair Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tissue Culture Innovations?
FDA lists 6 510(k) clearances under the applicant name “Tissue Culture Innovations” (first 1986, latest 1986), 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 Tissue Culture Innovations?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tissue Culture Innovations is 9 days.
Which FDA product codes appear under Tissue Culture Innovations?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 5); KIP (Formulations, Balanced Salt Solutions, 1).
Next steps
- See all 6 Tissue Culture Innovations clearances with predicates and recalls
- Run predicate analysis for product code KIT, Tissue Culture Innovations'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.