Company
Misys Healthcare Systems
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
32recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | 29 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2005 | Misys Healthcare Systems Misys Laboratory version 6.1 - Microbiology Module Terminated |
JQP | None listed |
| Jun 28, 2005 | Misys Healthcare Systems Mysis Laboratory version 6.1 Terminated |
JQP | None listed |
| Jun 28, 2005 | Misys Healthcare Systems Misys Laboratory with Lab Access Results application for versions 5.3 and later. Terminated |
JQP | None listed |
| Jul 20, 2004 | Misys Healthcare Systems Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results. Terminated |
JQP | None listed |
| Jul 20, 2004 | Misys Healthcare Systems Calculator/Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Jul 20, 2004 | Misys Healthcare Systems Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2. Terminated |
JQP | None listed |
| Dec 18, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use. Terminated |
JQP | None listed |
| Oct 15, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Sep 11, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Sep 11, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System version 5.3 Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module Terminated |
JQP | None listed |
| Jul 15, 2003 | Misys Healthcare Systems Misys Laboratory System, versions 5.2, 5.23 and 5.3 Terminated |
JQP | None listed |
| Jul 2, 2003 | Misys Healthcare Systems Mysys Laboratory System Version 5.3 Terminated |
JQP | None listed |
| Jul 2, 2003 | Misys Healthcare Systems Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3 Terminated |
JQP | None listed |
| Jun 17, 2003 | Misys Healthcare Systems Misys Laboratory System, version 5.3 Terminated |
JQP | None listed |
| Jun 5, 2003 | Misys Healthcare Systems Misys Commercial Laboratory version 2.x thru 3.4.1 Terminated |
JQP | None listed |
| May 29, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.2, 5.23, 5.3, 5.3.1 and 5.3.2. Terminated |
JQP | None listed |
| May 9, 2003 | Misys Healthcare Systems Misys Laboratory System version 5.3 Terminated |
None listed | |
| May 9, 2003 | Misys Healthcare Systems Misys Commercial Laboratory, Laboratory Information System, version 3.4.1 Terminated |
None listed | |
| May 9, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.23 and 5.3 Terminated |
None listed | |
| May 8, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.23 and 5.3 Terminated |
JQP | None listed |
| Apr 2, 2003 | Misys Healthcare Systems Misys Laboratory version 5.3 Terminated |
JQP | None listed |
| Mar 26, 2003 | Misys Healthcare Systems Misys Laboratory,
Calculator/Data processing Module for Clinical Use (21 CFR 862.2100)
Misys Laboratory GUI Version 5.3 Terminated |
JQP | None listed |
| Mar 21, 2003 | Misys Healthcare Systems Misys Laboratory System Version 5.3 Terminated |
JQP | None listed |
| Mar 13, 2003 | Misys Healthcare Systems Misys Laboratory System Version 5.3 Terminated |
JQP | None listed |
| Mar 12, 2003 | Misys Healthcare Systems Misys Laboratory System , Versions 5.2, 5.23 and 5.3 Terminated |
JQP | None listed |
| Mar 6, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.2, 5.23 and 5.3 Terminated |
JQP | None listed |
| Mar 6, 2003 | Misys Healthcare Systems Misys Laboratory System Versions 5.2, 5.23 and 5.3 Terminated |
JQP | None listed |
| Jan 30, 2003 | Misys Healthcare Systems Misys Laboratory version 5.3 Terminated |
JQP | None listed |
| Jan 30, 2003 | Misys Healthcare Systems Misys Laboratory, GUI version 5.3 Terminated |
JQP | None listed |