CHOLINESTERASE REAGENT— 510(k) K791725

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K791725 for CHOLINESTERASE REAGENT, Substantially Equivalent on 1979-10-17. Applicant: Gilford Diagnostics. Device class: 1.

Clearance details

Applicant: Gilford Diagnostics
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1979-08-31
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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 Gilford Diagnostics

K832094 — BILIRUBIN CALIBRATORS & CONTROL1983-08-11
K831843 — GILCHEM TOTAL BILIRUBIN REAGENT1983-07-18
K831844 — DIRECT BILIRUBIN REAGENT1983-07-18
K823709 — TRIGLYCERIDE REAGENT (UV)1983-01-07
K822739 — AHBD1982-10-18

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