SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L— 510(k) K965240

Clearance details

Applicant

Beckman Instruments, Inc.

Product code

Code JJE

Device class

Class 1

Regulation

21 CFR 862.2160

Advisory panel

Clinical Chemistry

Date received

1996-12-30

Decision date

1997-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

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• K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 344691998-09-17
• K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER1998-07-14
• K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT1998-05-08
• K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 332111998-05-01
• K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 335051998-03-18

Death

6

Injury

441

Malfunction

25,011

Other

1

Total

25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1951-2013 — ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.Class II·Terminated·Beckman Coulter Inc.·20100922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965240.