510(k) K123256 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Jul 3, 2013 |
| Received | Oct 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2017 | The Binding Site Group, Ltd. Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK.
Product is designed for the quantitative Terminated |
DEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.