Cleared Traditional

CHEM I CLINICAL ANALYZER URINE MAGNESIUM

K901124 · Technicon Instruments Corp. · Chemistry
May 1990
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K901124 is an FDA 510(k) clearance for the CHEM I CLINICAL ANALYZER URINE MAGNESIUM, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on May 14, 1990, 63 days after receiving the submission on March 12, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K901124 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1990
Decision Date May 14, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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