Company ยท US
Beckman Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1998. Name variants (Inc, Corp, punctuation) are merged.
281510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 7 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 |
| CEK | Biuret (Colorimetric), Total Protein | 4 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 4 |
| DDG | Transferrin, Antigen, Antiserum, Control | 4 |
| DEW | Igg, Antigen, Antiserum, Control | 4 |
| DFH | Kappa, Antigen, Antiserum, Control | 4 |
| DHR | System, Test, Rheumatoid Factor | 4 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 4 |
| MSJ | Apolipoproteins | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 1998 | K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 Beckman Instruments, Inc. | LGD |
| Jul 14, 1998 | K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CEC |
| May 8, 1998 | K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT Beckman Instruments, Inc. | DKB |
| May 1, 1998 | K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 Beckman Instruments, Inc. | LOJ |
| Mar 18, 1998 | K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 Beckman Instruments, Inc. | JHI |
| Feb 20, 1998 | K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 Beckman Instruments, Inc. | LTJ |
| Feb 17, 1998 | K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT Beckman Instruments, Inc. | DEB |
| Dec 24, 1997 | K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT Beckman Instruments, Inc. | JBQ |
| Dec 17, 1997 | K974452 | VIGIL LIPID CONTROL Beckman Instruments, Inc. | JJY |
| Dec 15, 1997 | K973932 | BECKMAN CALIBRATOR 2 (CAL2) Beckman Instruments, Inc. | JIX |
| Dec 1, 1997 | K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) Beckman Instruments, Inc. | JIX |
| Nov 24, 1997 | K974050 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT Beckman Instruments, Inc. | DCK |
| Nov 24, 1997 | K973696 | SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT Beckman Instruments, Inc. | LCP |
| Nov 20, 1997 | K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT Beckman Instruments, Inc. | JZG |
| Nov 10, 1997 | K974075 | ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | MMI |
| Oct 31, 1997 | K973966 | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CDP |
| Oct 31, 1997 | K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CHP |
| Sep 22, 1997 | K973069 | SYNCHRON SYSTEMS METHADONE REAGENT Beckman Instruments, Inc. | DJR |
| Aug 20, 1997 | K971958 | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT Beckman Instruments, Inc. | DDG |
| Aug 13, 1997 | K972819 | VIGIL TDM CONTROLS Beckman Instruments, Inc. | DIF |
| Jun 27, 1997 | K971602 | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT Beckman Instruments, Inc. | DHR |
| Jun 11, 1997 | K971505 | SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT Beckman Instruments, Inc. | CHH |
| Jun 11, 1997 | K964842 | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT Beckman Instruments, Inc. | CZW |
| Jun 4, 1997 | K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT Beckman Instruments, Inc. | CHI |
| Jun 3, 1997 | K971788 | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR Beckman Instruments, Inc. | DHR |
| Jun 3, 1997 | K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR Beckman Instruments, Inc. | DMT |
| Jun 3, 1997 | K971283 | SYNCHRON SYSTEMS CAL 5 PLUS Beckman Instruments, Inc. | JIX |
| May 23, 1997 | K971333 | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD Beckman Instruments, Inc. | JIX |
| May 21, 1997 | K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT Beckman Instruments, Inc. | KNK |
| May 16, 1997 | K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT Beckman Instruments, Inc. | KLI |
| May 9, 1997 | K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT Beckman Instruments, Inc. | DDS |
| May 8, 1997 | K971287 | SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS Beckman Instruments, Inc. | DKB |
| Apr 29, 1997 | K964695 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT Beckman Instruments, Inc. | DCF |
| Apr 25, 1997 | K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) Beckman Instruments, Inc. | DEM |
| Apr 25, 1997 | K964762 | IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT Beckman Instruments, Inc. | DDB |
| Apr 21, 1997 | K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS Beckman Instruments, Inc. | MSJ |
| Apr 21, 1997 | K965033 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT Beckman Instruments, Inc. | MGA |
| Apr 17, 1997 | K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS Beckman Instruments, Inc. | LAS |
| Apr 17, 1997 | K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT Beckman Instruments, Inc. | JIQ |
| Mar 24, 1997 | K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT Beckman Instruments, Inc. | LKL |
| Mar 19, 1997 | K963976 | IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT Beckman Instruments, Inc. | DDG |
| Mar 10, 1997 | K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc. | JJE |
| Mar 6, 1997 | K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT Beckman Instruments, Inc. | DEW |
| Mar 6, 1997 | K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT Beckman Instruments, Inc. | JZH |
| Mar 6, 1997 | K963974 | IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN Beckman Instruments, Inc. | DEW |
| Feb 11, 1997 | K964009 | IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS Beckman Instruments, Inc. | DNO |
| Feb 10, 1997 | K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG Beckman Instruments, Inc. | DFH |
| Feb 10, 1997 | K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT Beckman Instruments, Inc. | MSJ |
| Feb 10, 1997 | K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) Beckman Instruments, Inc. | DEW |
| Feb 4, 1997 | K963673 | IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS Beckman Instruments, Inc. | KLT |
Newest 50 of 281.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||