Home / 510(k) Clearances / K991707

510(k) K991707

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 by Beckman — Product Code DHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1999
Date Received
May 19, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Carcinoembryonic Antigen
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Beckman

  • K971534 — SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL (May 21, 1997)
  • K935362 — P-AMYLASE CONTROL (January 27, 1994)
  • K904219 — SYNCHRON CX 7 CLINICAL ANALYZER (October 22, 1990)
  • K904220 — SYNCHRON CX4-CE (October 15, 1990)
  • K893583 — BECKMAN CHOLINESTERASE REAGENT KIT (August 15, 1989)

Other clearances for product code DHX

  • K223921 — Access CEA (September 22, 2023)
  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K200215 — ADVIA Centaur CEA Assay (April 13, 2020)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K080194 — VIDAS CEA (S) ASSAY (October 9, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K041322 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (June 17, 2004)
  • K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (May 6, 2003)
  • K023893 — ST AIA-PACK CEA ENZYME IMMUNOASSAY (December 18, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)