510(k) K103615 ยท CDN Urease, Photometric, Urea Nitrogen
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | Dec 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2013 | Alfa Wassermann, Inc. Alfa Wassermann System Diluent 750 mL
Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006
Alfa Wassermann B.V. Pompmolenlaan 24
3447 GK, Woerden T Terminated |
CEO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.