CJ Healthtech Holdings, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “CJ Healthtech Holdings, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QBI | Acute Coronary Syndrome Event Detector | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150009 | PMA | Guardian System | 2018-04-09 |
Recalls
openFDA lists no recalls under a recalling firm named CJ Healthtech Holdings, LLC.
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 CJ Healthtech Holdings, LLC?
FDA lists 0 510(k) clearances under the applicant name “CJ Healthtech Holdings, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under CJ Healthtech Holdings, LLC?
The most frequent FDA product codes under this applicant name are QBI (Acute Coronary Syndrome Event Detector, 1).
Next steps
- See all 0 CJ Healthtech Holdings, LLC clearances with predicates and recalls
- Run predicate analysis for product code QBI, CJ Healthtech Holdings, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.