Spectra Science: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Spectra Science”, plus 2 PMA decisions, across 2 product codes in 2 review panels. 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 |
|---|---|---|---|
| MOA | Analyzer, Diagnostic, Fiber Optic (Colon) | 1 | 0 |
| MWM | Sensor, Electro-Optical (For Cervical Cancer) | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040028 | PMA | LUMA CERVICAL IMAGING SYSTEM | 2006-03-16 |
| P990050 | PMA | OPTICAL BIOPSY(TM) SYSTEM | 2000-11-14 |
Recalls
openFDA lists no recalls under a recalling firm named Spectra Science.
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.
- Spectra Medical Devices, Inc. (8 510(k)s)
- Spectra, Inc. (1 510(k)s)
- Spectra Gases, Inc. (1 510(k)s)
- Spectra-Physics, Inc. (1 510(k)s)
- Spectra-Shield, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectra Science?
FDA lists 0 510(k) clearances under the applicant name “Spectra Science”, plus 2 PMA decisions, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Spectra Science?
The most frequent FDA product codes under this applicant name are MOA (Analyzer, Diagnostic, Fiber Optic (Colon), 1); MWM (Sensor, Electro-Optical (For Cervical Cancer), 1).
Next steps
- See all 0 Spectra Science clearances with predicates and recalls
- Run predicate analysis for product code MOA, Spectra Science'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.