510(k) K030443 ยท KNW Instrument, Biopsy
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
| Applicant | Nastech Pharmaceutical Company, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, May 9, 2003 |
| Received | Feb 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2013 | Atossa Genetics, Inc. Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, B Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.