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510(k) K893583

BECKMAN CHOLINESTERASE REAGENT KIT by Beckman — Product Code DIH

K893583 is an FDA 510(k) premarket notification submitted by Beckman for the device "BECKMAN CHOLINESTERASE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Beckman has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
May 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

Other clearances by Beckman

  • K991707 — MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, (June 1, 1999)
  • 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)

Other clearances for product code DIH

  • K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (February 7, 2011)
  • K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM (July 3, 2006)
  • K051444 — SENTINEL CHOLINESTERASE LIQUID (June 20, 2005)
  • K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (February 21, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K013750 — ADVIA 1650 CHOLINESTERASE ASSAY (January 18, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001344 — ADVIA IMS (June 26, 2000)
  • K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (November 26, 1996)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)

FDA data resources