Company
Abbott Laboratories MPG
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)
13recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| JJI | Analyzer, Enzyme, For Clinical Use | 1 |
| LIG | Radioassay, Intrinsic Factor Blocking Antibody | 1 |
| MOI | System, Test, Immunological, Antigen, Tumor | 1 |
| NRP | Sirolimus Test System | 1 |
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) |
|---|---|---|---|
| Jun 14, 2007 | Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Ab Terminated |
MMI | K041192 |
| Mar 8, 2007 | Abbott Laboratories MPG ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21 Terminated |
JJI | None listed |
| Feb 15, 2007 | Abbott Laboratories MPG IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bo Terminated |
NRP | K042411 |
| Jan 11, 2007 | Abbott Laboratories MPG ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 t Terminated |
CEP | None listed |
| Jul 18, 2006 | Abbott Laboratories MPG CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (hu Terminated |
MOI | K963926 K964407 |
| Jul 4, 2006 | Abbott Laboratories MPG ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
DBF | K983759 |
| May 11, 2006 | Abbott Laboratories MPG ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and Terminated |
LIG | K984108 |
| Feb 14, 2006 | Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | K041192 |
| Jan 18, 2006 | Abbott Laboratories MPG ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DDR | K042920 |
| Sep 14, 2005 | Abbott Laboratories MPG XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA Terminated |
DIF | K873183 |
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Ab Terminated |
JHI | K903219 |
| Aug 24, 2005 | Abbott Laboratories MPG ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Labora Terminated |
JHI | K965116 |
| Apr 28, 2005 | Abbott Laboratories MPG ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A. Terminated |
CGN | None listed |