510(k) K991430 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
SMARTPREP CENTRIFUGE SYSTEM
| Applicant | Harvest Technologies, LLC, Norwell MA, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2017 | Terumo BCT, Inc. HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO Terminated |
JQC | None listed |
| Oct 20, 2017 | Terumo BCT, Inc. HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO Terminated |
JQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.