510(k) K043267 ยท CEJ Tetraphenyl Borate, Colorimetry, Potassium
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Feb 10, 2005 |
| Received | Nov 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043267
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.