CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)— 510(k) K954626

Name: FDA 510(k) clearance K954626
Creator: U.S. Food and Drug Administration
Published: 1995-11-27

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K954626 for CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION), Substantially Equivalent on 1995-11-27. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 1995-10-03
Decision date: 1995-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXM

view all

K243498 — Alinity c Benzodiazepines Reagent Kit2024-12-11
K221765 — ONLINE DAT Benzodiazepines II2022-12-23
K190968 — CEDIA Benzodiazepine Assay2019-12-09
K173963 — DRI Benzodiazepine Assay2018-02-21
K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair2017-09-15

More clearances from Microgenics Corp.

view all

K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY2013-08-20
K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS2013-07-11
K123271 — ABBOTT PHENOBARBITAL ASSAY2013-04-26
K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO2011-06-29
K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY2011-04-08

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