Company ยท US
Abbott Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 7 |
| GKZ | Counter, Differential Cell | 6 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 3 |
| GIF | Diluent, Blood Cell | 2 |
| GKH | Apparatus, Automated Blood Cell Diluting | 2 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| KHO | Fluorometer, For Clinical Use | 1 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 1 |
| MJZ | Kit, Direct Antigen, Positive Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 1997 | K964185 | IMX CA 125 Abbott Diagnostics | LTK |
| Aug 13, 1997 | K972182 | ABBOTT STREP A CONTROLS Abbott Diagnostics | MJZ |
| Oct 18, 1996 | K961439 | ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics | GKZ |
| Apr 18, 1989 | K890491 | CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER Abbott Diagnostics | GKZ |
| Apr 21, 1988 | K881242 | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN Abbott Diagnostics | GJZ |
| Mar 31, 1988 | K881130 | CELL-DYN ISOTONIC DILUENT Abbott Diagnostics | GIF |
| Sep 9, 1987 | K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. Abbott Diagnostics | GGK |
| Sep 9, 1987 | K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT Abbott Diagnostics | GIF |
| Sep 8, 1987 | K873408 | MODEL 690 SPECTROPHOTOMETER Abbott Diagnostics | JJQ |
| Aug 6, 1987 | K872761 | CELL-DYN 610 HEMATOLOGY ANALYZER Abbott Diagnostics | GKZ |
| Mar 17, 1987 | K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics | GKZ |
| Jan 1, 1986 | K854368 | CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER Abbott Diagnostics | GKZ |
| Sep 17, 1985 | K852371 | CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY Abbott Diagnostics | GKZ |
| Sep 3, 1985 | K852372 | CELL-DYN BRAND HEMATOLOGY REAGENTS Abbott Diagnostics | JPK |
| Jul 5, 1985 | K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR Abbott Diagnostics | GKH |
| Mar 26, 1985 | K845019 | CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Sep 14, 1984 | K842786 | DYNA-LYTE 2000 Abbott Diagnostics | CEM |
| Sep 6, 1984 | K842446 | DILU-MATIC 140 Abbott Diagnostics | GKH |
| Mar 2, 1984 | K840170 | CELL-DYN 100 WHOLE BLOOD PLATELET Abbott Diagnostics | GKL |
| Sep 26, 1983 | K832643 | CELL-DYN 900 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Aug 24, 1983 | K832206 | SPECTROPHOTOMETER #390 Abbott Diagnostics | JJQ |
| Jul 18, 1983 | K832038 | CELL-DYN 300 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Jul 18, 1983 | K831368 | CELL-DYN 400 HEMOTOLOGY ANALYZER Abbott Diagnostics | GKL |
| Apr 5, 1983 | K830624 | FLUOROMETER, GENERAL USE Abbott Diagnostics | KHO |
| Dec 28, 1982 | K823344 | HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Oct 8, 1982 | K822720 | MODEL 340 SPECTROPHOTOMETER Abbott Diagnostics | JJQ |
| Jun 9, 1981 | K803218 | CELL DYN 800 HEMATOLOGY ANALYZER Abbott Diagnostics | GKL |
| Feb 10, 1981 | K810135 | MODEL AM 721 ELECTROLYTE ANALYZER Abbott Diagnostics | JGS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||