CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS— 510(k) K944606

Name: FDA 510(k) clearance K944606
Creator: U.S. Food and Drug Administration
Published: 1994-11-30

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K944606 for CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS, Substantially Equivalent on 1994-11-30. Applicant: Beckman-Diagnostic Systems Group. Device class: 2.

Clearance details

Applicant: Beckman-Diagnostic Systems Group
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1994-09-19
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Beckman-Diagnostic Systems Group

view all

K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS1994-12-12
K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS1994-12-07
K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM1994-12-07
K942676 — SYNCHRON CX3 DELTA1994-11-02
K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT1994-07-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.