510(k) K843962 ยท JPK Mixture, Hematology Quality Control
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 1, 1984 |
| Received | Oct 11, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2023 | R & D Systems, Inc. R&D CBC-3D Hematology Control:
(1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N;
(2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Control Terminated |
JPK | None listed |
| 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 |
| Jul 20, 2004 | R & D Systems,Inc ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and
Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.