510(k) K053401 ยท CIC Cresolphthalein Complexone, Calcium
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
| Applicant | Arkray, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Mar 24, 2006 |
| Received | Dec 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2016 | Arkray Factory USA, Inc. arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine.
For the in vitro quantitative determi Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.