Home / 510(k) Clearances / K944606

510(k) K944606

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS by Beckman-Diagnostic Systems Group — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
September 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Beckman-Diagnostic Systems Group

  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (December 7, 1994)
  • K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM (December 7, 1994)
  • K942676 — SYNCHRON CX3 DELTA (November 2, 1994)
  • K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (July 6, 1994)
  • K934068 — BECKMAN DIRECT BILIRUBIN REAGENT (April 26, 1994)
  • K936184 — VIGIL PRX CHEMISTRY CONTROL (April 15, 1994)
  • K934271 — BECKMAN SYNCHRON LACTATE REAGENT (November 9, 1993)
  • K934046 — BECKMAN CHOLESTEROL REAGENT (October 28, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)

Other clearances for product code DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)