P-AMYLASE CONTROL— 510(k) K935362

Clearance details

Applicant

Beckman

Product code

Code JJX

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

1993-11-04

Decision date

1994-01-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

• K170678 — Beta-CrossLaps CalCheck 52017-04-04
• K162173 — Elecsys CYFRA 21-1 CalCheck 52017-01-12
• K162514 — Multichem A1c2016-10-26
• K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose2016-08-10
• K161522 — LIAISON EBV IgM Serum Control Set2016-06-30

• K991707 — MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 332061999-06-01
• K971534 — SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL1997-05-21
• K904219 — SYNCHRON CX 7 CLINICAL ANALYZER1990-10-22
• K904220 — SYNCHRON CX4-CE1990-10-15
• K893583 — BECKMAN CHOLINESTERASE REAGENT KIT1989-08-15

Other

2

Total

2

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 →