Cleared Traditional

K872311 - ABBOTT A-GENT LIQUID MAGNESIUM REAGENT (FDA 510(k) Clearance)

Jul 1987
Decision
22d
Days
Class 1
Risk

K872311 is an FDA 510(k) clearance for the ABBOTT A-GENT LIQUID MAGNESIUM REAGENT. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 9, 1987, 22 days after receiving the submission on June 17, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K872311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1987
Decision Date July 09, 1987
Days to Decision 22 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