CARESIDE CHOLINESTERASE— 510(k) K002792

Substantially Equivalent

Careside, Inc.

FDA 510(k) clearance K002792 for CARESIDE CHOLINESTERASE, Substantially Equivalent on 2000-11-08. Applicant: Careside, Inc.. Device class: 1.

Clearance details

Applicant: Careside, Inc.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 2000-09-07
Decision date: 2000-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIH

K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A537222011-02-07
K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM2006-07-03
K051444 — SENTINEL CHOLINESTERASE LIQUID2005-06-20
K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)2003-02-21
K023992 — WIENER LAB COLINESTERASA AA2003-02-12

More clearances from Careside, Inc.

K020484 — CARESIDE LDH2002-07-03
K020486 — CARESIDE GGT2002-07-01
K020487 — CARESIDE ALT2002-06-04
K020488 — CARESIDE TRGLYCERIDE2002-04-15
K001462 — CARESIDE HEMOGLOBIN2000-08-21

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