Agilent Technologies Singapore (International) Pte , Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Agilent Technologies Singapore (International) Pte , Ltd.”, plus 2 PMA decisions, across 2 product codes 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 |
|---|---|---|---|
| MVC | System, Test, Her-2/Neu, Ihc | 1 | 0 |
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | 1 | 0 |
Review panels
- Pathology (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040005 | PMA | DAKOCYTOMATION HER2 FISH PHARMDX KIT | 2005-05-03 |
| P980018 | PMA | DAKO HERCEPTEST | 1998-09-25 |
Recalls
openFDA lists no recalls under a recalling firm named Agilent Technologies Singapore (International) Pte , Ltd..
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.
- Agilent Technologies, Inc. (45 510(k)s)
- Agilent Technologies Deutschland GmbH (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Agilent Technologies Singapore (International) Pte , Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Agilent Technologies Singapore (International) Pte , Ltd.”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Agilent Technologies Singapore (International) Pte , Ltd.?
The most frequent FDA product codes under this applicant name are MVC (System, Test, Her-2/Neu, Ihc, 1); MVD (System, Test, Her-2/Neu, Nucleic Acid Or Serum, 1).
Next steps
- See all 0 Agilent Technologies Singapore (International) Pte , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MVC, Agilent Technologies Singapore (International) Pte , Ltd.'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.