FDA 510(k) Applications Submitted by BECKMAN INSTRUMENTS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K981403 04/17/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT BECKMAN INSTRUMENTS, INC.
K971602 05/01/1997 ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT BECKMAN INSTRUMENTS, INC.
K971788 05/14/1997 SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR BECKMAN INSTRUMENTS, INC.
K963048 08/06/1996 IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT BECKMAN INSTRUMENTS, INC.
K963061 08/07/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC.
K963673 09/13/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS BECKMAN INSTRUMENTS, INC.
K963868 09/26/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) BECKMAN INSTRUMENTS, INC.
K963974 10/02/1996 IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN BECKMAN INSTRUMENTS, INC.
K963976 10/04/1996 IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT BECKMAN INSTRUMENTS, INC.
K964009 10/07/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS BECKMAN INSTRUMENTS, INC.
K973813 10/07/1997 IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT BECKMAN INSTRUMENTS, INC.
K973932 10/15/1997 BECKMAN CALIBRATOR 2 (CAL2) BECKMAN INSTRUMENTS, INC.
K973928 10/15/1997 BECKMAN URINE PROTEIN CALIBRATOR (UCAL) BECKMAN INSTRUMENTS, INC.
K974050 10/24/1997 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC.
K964260 10/25/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG BECKMAN INSTRUMENTS, INC.
K964257 10/25/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT BECKMAN INSTRUMENTS, INC.
K974110 10/31/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT BECKMAN INSTRUMENTS, INC.
K964762 11/27/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT BECKMAN INSTRUMENTS, INC.
K964766 11/27/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) BECKMAN INSTRUMENTS, INC.
K964843 12/03/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT BECKMAN INSTRUMENTS, INC.
K974564 12/05/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT BECKMAN INSTRUMENTS, INC.
K965033 12/17/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT BECKMAN INSTRUMENTS, INC.
K965035 12/17/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT BECKMAN INSTRUMENTS, INC.
K974816 12/23/1997 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 BECKMAN INSTRUMENTS, INC.
K981354 04/14/1998 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 BECKMAN INSTRUMENTS, INC.
K971210 04/02/1997 SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS BECKMAN INSTRUMENTS, INC.
K964695 11/22/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT BECKMAN INSTRUMENTS, INC.
K964781 11/27/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT BECKMAN INSTRUMENTS, INC.
K974075 10/29/1997 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC.
K970314 01/24/1997 SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS BECKMAN INSTRUMENTS, INC.
K965108 12/20/1996 SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT BECKMAN INSTRUMENTS, INC.
K971203 04/01/1997 SYNCHRON SYSTEMS THYROXINE REAGENT BECKMAN INSTRUMENTS, INC.
K971333 04/10/1997 SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD BECKMAN INSTRUMENTS, INC.
K971958 05/28/1997 SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT BECKMAN INSTRUMENTS, INC.
K972819 07/29/1997 VIGIL TDM CONTROLS BECKMAN INSTRUMENTS, INC.
K973069 08/18/1997 SYNCHRON SYSTEMS METHADONE REAGENT BECKMAN INSTRUMENTS, INC.
K973696 09/26/1997 SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT BECKMAN INSTRUMENTS, INC.
K963062 08/07/1996 IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 BECKMAN INSTRUMENTS, INC.
K963286 08/21/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT BECKMAN INSTRUMENTS, INC.
K963427 08/30/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT BECKMAN INSTRUMENTS, INC.
K964010 10/07/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT BECKMAN INSTRUMENTS, INC.
K964842 12/03/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT BECKMAN INSTRUMENTS, INC.
K973448 09/11/1997 ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 BECKMAN INSTRUMENTS, INC.
K973743 10/01/1997 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC.
K961256 04/01/1996 SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT BECKMAN INSTRUMENTS, INC.
K974452 11/25/1997 VIGIL LIPID CONTROL BECKMAN INSTRUMENTS, INC.
K980173 01/20/1998 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 BECKMAN INSTRUMENTS, INC.
K982250 06/26/1998 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC.
K973966 10/17/1997 ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC.
K960485 02/02/1996 SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS BECKMAN INSTRUMENTS, INC.
K970905 03/12/1997 SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT BECKMAN INSTRUMENTS, INC.
K970919 03/12/1997 SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT BECKMAN INSTRUMENTS, INC.
K971283 04/07/1997 SYNCHRON SYSTEMS CAL 5 PLUS BECKMAN INSTRUMENTS, INC.
K971287 04/07/1997 SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS BECKMAN INSTRUMENTS, INC.
K971505 04/25/1997 SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT BECKMAN INSTRUMENTS, INC.
K971506 04/25/1997 SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR BECKMAN INSTRUMENTS, INC.
K962294 06/14/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM BECKMAN INSTRUMENTS, INC.
K955644 12/12/1995 SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM BECKMAN INSTRUMENTS, INC.
K955675 12/15/1995 SYNCHRON SYSTEMS PROPOXYPHENE REAGENT BECKMAN INSTRUMENTS, INC.
K955677 12/15/1995 SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT BECKMAN INSTRUMENTS, INC.
K955676 12/15/1995 SYNCHRON SYSTEMS METHAQUALONE REAGENT BECKMAN INSTRUMENTS, INC.
K965240 12/30/1996 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L BECKMAN INSTRUMENTS, INC.
K953077 06/30/1995 PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM BECKMAN INSTRUMENTS, INC.


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