510(k) K983212 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
ABBOTT ARCHITECT TESTOSTERONE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | Abbott Laboratories ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87;
ARCHITECT i2000SR REF 03M74-02/3M74;
ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Open, Classified |
JJE | None listed |
| Sep 29, 2021 | Abbott Laboratories ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
ARCHITECT c8000 REF 01G06-11/1G06;
ARCHITECT c16000 REF 03L77-01/3L77; Open, Classified |
JJE | None listed |
| Apr 9, 2010 | Abbott Laboratories, Inc ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip Terminated |
JJE | None listed |
| Nov 9, 2009 | Abbott Laboratories, Inc ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit.
ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiomet Terminated |
JJE | None listed |
| Jun 19, 2007 | Abbott Laboratories, Inc ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX. Terminated |
JJE | None listed |
| Jun 19, 2007 | Abbott Laboratories, Inc ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX. Terminated |
JJE | None listed |
| May 9, 2007 | Abbott Laboratories, Inc ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, Irving, TX. Terminated |
JJE | None listed |
| May 9, 2007 | Abbott Laboratories, Inc ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX. Terminated |
JJE | None listed |
| Feb 7, 2007 | Abbott Laboratories, Inc ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX. Terminated |
JJE | None listed |
| Feb 7, 2007 | Abbott Laboratories, Inc ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX. Terminated |
JJE | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas Terminated |
JJE | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Terminated |
JJE | None listed |
| Dec 24, 2003 | Abbott Laboratories, Inc The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Terminated |
JQP | None listed |
| Aug 13, 2003 | Abbott Laboratories, Inc ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.