Cleared Traditional

K800327 - MAGNESIUM REAGENT
(FDA 510(k) Clearance)

K800327 · Alta Diagnostics, Inc. · Chemistry

Mar 1980

Decision

42d

Days

Class 1

Risk

K800327 is an FDA 510(k) clearance for the MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980, 42 days after receiving the submission on February 12, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number	K800327 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 1980
Decision Date	March 25, 1980
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—