Leica Biosystems: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Leica Biosystems”, 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.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVC | System, Test, Her-2/Neu, Ihc | 1 | 0 |
Review panels
- Pathology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P090015 | PMA | BOND ORACLE HER2 IHC SYSTEM | 2012-04-18 |
Recalls
openFDA lists no recalls under a recalling firm named Leica Biosystems.
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.
- Leica Biosystems Imaging, Inc. (5 510(k)s)
- Leica Microsystems (Schweiz) AG (3 510(k)s)
- Leica, Inc. (3 510(k)s)
- Leica Biosystems Newcastle, Ltd. (3 510(k)s)
- Leica Biosystems Newcastle, Limited (3 510(k)s)
- Leica Microsystems, Inc. (2 510(k)s)
- Leica Biosystems Richmond (1 510(k)s)
- Leica Microscopy Systems , Ltd. (1 510(k)s)
- Leica Microsystems, Inc. O.I.D. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Leica Biosystems?
FDA lists 0 510(k) clearances under the applicant name “Leica Biosystems”, 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 Leica Biosystems?
The most frequent FDA product codes under this applicant name are MVC (System, Test, Her-2/Neu, Ihc, 1).
Next steps
- See all 0 Leica Biosystems clearances with predicates and recalls
- Run predicate analysis for product code MVC, Leica Biosystems'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.