510(k) K141932 ยท OYE Flow Cytometric Reagents And Accessories.
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Apr 10, 2015 |
| Received | Jul 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2018 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coul Terminated |
OYE | None listed |
| Oct 2, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.
The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic dev Terminated |
OYE | None listed |
| Aug 21, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer System
The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. Terminated |
OYE | None listed |
| Apr 17, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1
Product Usage:
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using u Terminated |
OYE | None listed |
| Nov 21, 2016 | Beckman Coulter Inc. AQUIOS Lyse Reagent Kit, Catalog No. B23538
Product Usage:
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytomete Terminated |
OYE | None listed |
| Sep 28, 2016 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels. Terminated |
OYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.