510(k) K850755 ยท JPK Mixture, Hematology Quality Control
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 13, 1985 |
| Received | Feb 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2012 | Horiba Instruments, Inc dba Horiba Medical Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High).
Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accu Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.