510(k) K860719 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
| Applicant | Biotrack, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 23, 1986 |
| Received | Feb 26, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2003 | Roche Diagnostics Corp. CoaguChek Plus meter; catalog # 475729 and 12816001. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.