Siemens Medical Solutions Diagnostics Limited: FDA clearances and approvals
Siemens Medical Solutions Diagnostics Limited 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 |
|---|---|---|---|
| MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060005 | PMA | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS | 2007-05-11 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medical Solutions Diagnostics Limited.
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 Siemens Medical Solutions Diagnostics Limited have?
Siemens Medical Solutions Diagnostics Limited has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Siemens Medical Solutions Diagnostics Limited make?
Its most frequent FDA product codes are MTG (Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions, 1).
Has Siemens Medical Solutions Diagnostics Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Medical Solutions Diagnostics Limited. Related entities may recall under other names.
Next steps
- See all 0 Siemens Medical Solutions Diagnostics Limited clearances with predicates and recalls
- Run predicate analysis for product code MTG, Siemens Medical Solutions Diagnostics Limited'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.