MAGNESIUM ASSAY KIT, CAT.# 100-12— 510(k) K912825

Name: FDA 510(k) clearance K912825
Creator: U.S. Food and Drug Administration
Published: 1991-07-26

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K912825 for MAGNESIUM ASSAY KIT, CAT.# 100-12, Substantially Equivalent on 1991-07-26. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1991-06-26
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGJ

view all

K181748 — Magnesium2018-09-12
K173294 — Magnesium2018-05-18
K162200 — Randox RX Daytona Plus Magnesium (MG)2017-04-28
K162399 — Atellica CH Magnesium (Mg)2017-01-19
K122302 — ACE MAGNESIUM REGENT2012-08-27

More clearances from Diagnostic Chemicals, Ltd. (Usa)

view all

K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-252002-08-23
K974874 — BILIRUBIN-SL (TOTAL) ASSAY1998-02-12
K932556 — AMMONIA ASSAY CAT. NO. 200-021994-08-02
K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)1993-12-10
K932555 — DC-LINEATE CAT. NO. SE-0911993-08-19

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