510(k) K103340 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
| Applicant | Harvest Technologies, Corp., Plymouth MA, US |
| Decision | Substantially Equivalent, Dec 6, 2010 |
| Received | Nov 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103340
| 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.