PHENOBARBITAL TEST SYSTEM— 510(k) K860365

Name: FDA 510(k) clearance K860365
Creator: U.S. Food and Drug Administration
Published: 1986-03-17

Substantially Equivalent

Allied Instrumentation Laboratory

FDA 510(k) clearance K860365 for PHENOBARBITAL TEST SYSTEM, Substantially Equivalent on 1986-03-17. Applicant: Allied Instrumentation Laboratory. Device class: 2.

Clearance details

Applicant: Allied Instrumentation Laboratory
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1986-02-03
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DLZ

view all

K210858 — VITROS Chemistry Products PHBR Slides2021-08-13
K123271 — ABBOTT PHENOBARBITAL ASSAY2013-04-26
K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P332008-09-26
K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 035106202007-09-12
K011303 — RANDOX PHENOBARBITAL2001-07-02

More clearances from Allied Instrumentation Laboratory

view all

K861901 — MULTI-4 CO-OXIMETER CONTROL1986-06-17
K860286 — IL TEST PHENYTOIN1986-03-05
K853858 — IL TEST THEOPHYLLINE ASSAY1985-10-15
K852676 — IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS1985-07-22
K851933 — CLINICAL CHEMISTRY ANALYTICAL SYSTEM1985-06-10

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