Company
Abbott Laboratories HPD/ADD/GPRD
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)
43recalls (0 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | 13 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 5 |
| DJR | Enzyme Immunoassay, Methadone | 2 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 2 |
| MLM | Enzyme Immunoassay, Tracrolimus | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| DYG | Catheter, Flow Directed | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JFT | Fluorometric, Cortisol | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| LEH | Radioimmunoassay, Vancomycin | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 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) |
|---|---|---|---|
| Sep 30, 2004 | Abbott Laboratories HPD/ADD/GPRD Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Sep 18, 2004 | Abbott Laboratories HPD/ADD/GPRD XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Terminated |
JJE | None listed |
| Sep 14, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany Terminated |
LIG | K984108 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA Terminated |
GTZ | K971522 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | K974103 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A. Terminated |
NIG | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
JFT | K852927 K854419 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 600 Terminated |
CGN | K943691 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K943691 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K943691 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K943691 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K943691 K972232 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K972232 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K972232 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K972232 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12- Terminated |
CGN | K023397 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K023397 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K023397 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | K023397 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K983417 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
JQW | K894069 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Pentalumen TD Thermodilution Catheter, Sterile Terminated |
DYG | K812800 K832957 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LGQ | K813218 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LEH | K900940 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LCD | K840826 K871645 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
KLT | K802902 |
| Feb 24, 2004 | Abbott Laboratories HPD/ADD/GPRD 18 Gauge thin wall needle as part of a Central Venous Catheter Kit Terminated |
FOZ | K961552 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DJR | K884968 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DJR | K884968 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DKJ | K844070 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DIC | K871645 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DCK | K854542 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | K964185 K964929 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | K964020 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | K964020 K964185 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | K964185 |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | K964020 K964185 |
| Jan 6, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Dec 17, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MLM | None listed |
| Dec 11, 2003 | Abbott Laboratories HPD/ADD/GPRD Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Oct 24, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng Terminated |
MLM | None listed |
| Sep 11, 2003 | Abbott Laboratories HPD/ADD/GPRD AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
LPS | K992858 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD/GPRD IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LFX | K931059 |