Company
Abbott Laboratories HPD/ADD
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)
22recalls (0 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 10 |
| CEC | Radioimmunoassay, Free Thyroxine | 3 |
| MOI | System, Test, Immunological, Antigen, Tumor | 3 |
| FRN | Pump, Infusion | 2 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | 1 |
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | 1 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 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) |
|---|---|---|---|
| Aug 13, 2003 | Abbott Laboratories HPD/ADD 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 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K902834 |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | K934544 |
| Jul 24, 2003 | Abbott Laboratories HPD/ADD AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0) Terminated |
LOK | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD 75-1650 Drip Chambers .138rr; Abbott, Ashland, Ohio 44805; 800 drip chambers per case; Abbott Commodity 751650, Ashland Product #85-16500 Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD 96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968369, Ashland Product #85-56030 Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD 96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968366, Ashland Product #85-55960 Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below. Terminated |
FPA | K832755 K912103 |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed i Terminated |
FRN | K832755 K865059 +3 |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 95 different sets listed in the code information section below. Please not Terminated |
FPA | K770518 K832755 +3 |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (li Terminated |
FPA | K915571 K920736 +3 |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information Terminated |
FPA | K832755 K913308 +3 |
| Jun 17, 2003 | Abbott Laboratories HPD/ADD Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064 Terminated |
FPA | K791930 K832755 +2 |
| Jun 17, 2003 | Abbott Laboratories HPD/ADD T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laborator Terminated |
FPA | None listed |
| Jun 5, 2003 | Abbott Laboratories HPD/ADD LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289 Terminated |
FRN | K832755 |
| Jun 5, 2003 | Abbott Laboratories HPD/ADD LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Ma Terminated |
FPA | K791930 K915571 +1 |
| May 9, 2003 | Abbott Laboratories HPD/ADD Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LOM | None listed |
| Apr 24, 2003 | Abbott Laboratories HPD/ADD Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Terminated |
JLS | None listed |
| Apr 16, 2003 | Abbott Laboratories HPD/ADD Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following co Terminated |
LOJ | None listed |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL Terminated |
MOI | K964407 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u Terminated |
MOI | K963926 K964407 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbot Terminated |
MOI | K963926 |