510(k) K014225 ยท MSQ Test, Urea (Breath Or Blood)
BREATHTEK - UBIT UBT FOR H. PYLORI
| Applicant | Meretek Diagnostics, Inc., Nashville TN, US |
| Decision | Substantially Equivalent, Jan 17, 2002 |
| Received | Dec 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014225
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2007 | Meretek Diagnostics, Inc. BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO. Terminated |
MSQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.