510(k) K922823 ยท CGN Acid, Folic, Radioimmunoassay
ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 5, 1992 |
| Received | Jun 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2017 | Beckman Coulter Inc. Access 2 Immunoassay System, Catalog Number 81600N.
In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in hu Terminated |
JJE | None listed |
| Nov 6, 2017 | Beckman Coulter Inc. Access 2 Immunoassay System, Remanufactured, Catalog Number 386220.
In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrat Terminated |
JJE | None listed |
| Mar 15, 2017 | Beckman Coulter Inc. Access 2 Immunoassay Systems, Part No. 81600N
Product Usage:
The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qua Terminated |
JJE | None listed |
| Mar 15, 2017 | Beckman Coulter Inc. Access 2 assay Immunoassay System, Remanufactured, Part No. 386220
Product Usage:
The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, sem Terminated |
JJE | None listed |
| Mar 15, 2017 | Beckman Coulter Inc. UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638
Product Usage:
The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitativ Terminated |
JJE | None listed |
| May 17, 2016 | Beckman Coulter Inc. Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentra Terminated |
JJE | None listed |
| Feb 16, 2014 | Beckman Coulter Inc. Access 2 Immunoassay System Analyzer.
The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte con Terminated |
JJE | None listed |
| Nov 14, 2013 | Beckman Coulter Inc. Access 2 Immunoassay System, Part Number: 81600N
The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various an Terminated |
JJE | None listed |
| Apr 1, 2013 | Beckman Coulter Inc. Access Immunoassay System; P/N 107405S
Product Usage:
The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of va Terminated |
JJE | None listed |
| Dec 22, 2012 | Beckman Coulter Inc. Access Immunoassay System,
Access 2 Immunoassay System,
Synchron LXi 725 Clinical
System, UniCel DxC 600i
Synchron Access Clinical System
Part Numbers: Access 81600;
Access 2 81600N, 386220, A69186 Terminated |
JJE | None listed |
| Apr 6, 2012 | Beckman Coulter Inc. Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access.
Part Number: A19889, Access APF Wash Buffer REF 81907,
Part Number: A45144, Access APF Wash Buffer II REF A16792.
Terminated |
JJE | None listed |
| Jan 30, 2012 | Beckman Coulter Inc. Access Immunoassay Systems Part Number: 81600
Access 2 Immunoassay Systems Part Number: 81600N
Access Immunoassay Systems LXi 725 Part Number: 386200
Subsequent Product Codes: JGS
The Access/DxI Imm Terminated |
JJE | None listed |
| Dec 13, 2010 | Beckman Coulter Inc. Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N;
Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Ac Terminated |
JJE | None listed |
| Sep 21, 2008 | Beckman Coulter Inc Access and Access 2 Immunoassay System Terminated |
CGN | None listed |
| Aug 20, 2008 | Beckman Coulter Inc Access Power Supply Assembly Sled
Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use. Terminated |
JJE | None listed |
| Nov 30, 2004 | Beckman Coulter Inc Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer. Terminated |
CGN | None listed |
| Aug 21, 2003 | Beckman Coulter Inc Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29 Terminated |
KLS | None listed |
| Mar 29, 2003 | Beckman Coulter Inc Access 2 Immunoassay System Terminated |
None listed | |
| Mar 6, 2003 | Beckman Coulter Inc Access and Access 2 Immunoassay Systems
862.2160 Discrete photometric chemistry analyzer for clinical use. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.