Home / 510(k) Clearances / K002792

510(k) K002792

CARESIDE CHOLINESTERASE by Careside, Inc. — Product Code DIH

K002792 is an FDA 510(k) premarket notification submitted by Careside, Inc. for the device "CARESIDE CHOLINESTERASE". The FDA issued a decision of Substantially Equivalent on November 8, 2000. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Careside, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2000
Date Received
September 7, 2000
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 Careside, Inc.

  • K020484 — CARESIDE LDH (July 3, 2002)
  • K020486 — CARESIDE GGT (July 1, 2002)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K993771 — CARESIDE DIRECT BILIRUBIN (December 27, 1999)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K992475 — CARESIDE CO2, TOTAL (September 15, 1999)
  • K991717 — CARESIDE MG (August 10, 1999)
  • K991371 — CARESIDE AMMONIA (August 3, 1999)

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)
  • K001344 — ADVIA IMS (June 26, 2000)
  • K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (November 26, 1996)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)
  • K955498 — CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (January 24, 1996)

FDA data resources