Diabetes Sentry Products, LLC: FDA clearances and approvals
Diabetes Sentry Products, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMY | Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810044 | PMA | DIABETES SENTRY | 1982-07-08 |
Recalls
openFDA lists no recalls under a recalling firm named Diabetes Sentry Products, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Diabetes Sentry Products, LLC have?
Diabetes Sentry Products, LLC has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Diabetes Sentry Products, LLC make?
Its most frequent FDA product codes are LMY (Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions, 1).
Has Diabetes Sentry Products, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Diabetes Sentry Products, LLC. Related entities may recall under other names.
Next steps
- See all 0 Diabetes Sentry Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code LMY, Diabetes Sentry Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.