Abbott Laboratories - FDA 510(k) Cleared Devices

Cleared May 16, 2001

CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...

K011217 · DQO

Cardiovascular · 26d

Cleared May 01, 2001

ABBOTT ACCLAIM ENCORE, MODEL 12237

K011096 · FRN

General Hospital · 21d

Cleared Apr 06, 2001

MODIFICATION TO PLUM XL INFUSION PUMP

K010924 · FRN

General Hospital · 10d

Cleared Jan 08, 2001

STERILE PISTON SYRINGE

K002717 · FMF

General Hospital · 130d

Cleared Nov 13, 2000

SOF-TACT DIABETES MANAGEMENT SYSTEM

K001993 · LFR

Chemistry · 137d

Cleared Oct 05, 2000

SPIROL EPIDURAL CATHETER

K000886 · BSO

Anesthesiology · 199d

Cleared Aug 10, 2000

LIFESHIELD ADDITIVE PIERCING PIN

K002006 · FPA

General Hospital · 38d

Cleared Jul 27, 2000

MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE

K001616 · FOZ

General Hospital · 63d

Cleared Jul 20, 2000

ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP

K002126 · FRN

General Hospital · 6d

Cleared May 25, 2000

ABBOTT IMX GLYCATED HEMOGLOBIN II

K992085 · LCP

Hematology · 339d

Cleared Mar 24, 2000

ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...

K000821 · FRN

General Hospital · 10d

Cleared Dec 22, 1999

ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...

K994039 · FRN

General Hospital · 23d

Cleared Nov 24, 1999

ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK

K992710 · JJY

Immunology · 105d

Cleared Nov 01, 1999

ABBOTT ARCHITECT GLYCATED HEMOGLOBIN

K991483 · LCP

Hematology · 187d

Cleared Oct 25, 1999

ABBOTT AXSYM HOMOCYSTEINE

K992858 · LPS

Chemistry · 61d

Cleared Oct 05, 1999

ALCYON 300I (WITH ISE MODULE) ANALYZER

K993083 · CEM

Chemistry · 20d

Cleared Sep 24, 1999

MODIFICATION OF: CELL-DYN 1200 SYSTEM

K992444 · GKZ

Hematology · 64d

Cleared Jul 09, 1999

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...

K991605 · GKZ

Hematology · 60d

Cleared Jun 23, 1999

CELL-DYN 1200 SYSTEM

K991142 · GKZ

Hematology · 79d

Cleared Jun 01, 1999

CRP

K991372 · DCN

Immunology · 42d

Cleared May 28, 1999

MODIFICATION TO ALCYON DIRECT BILIRUBIN

K991175 · CIG

Chemistry · 60d

Cleared May 13, 1999

ACCLAIM INFUSION PUMP

K991501 · FRN

General Hospital · 14d

Cleared May 11, 1999

ABBOTT ARCHITECT CEA

K990774 · DHX

Immunology · 63d

Cleared Mar 08, 1999

RF

K990035 · DHR

Immunology · 61d

Cleared Feb 22, 1999

FACT PLUS ONE STEP PREGNANCY TEST

K990373 · LCX

Chemistry · 14d