MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)— 510(k) K860367

Name: FDA 510(k) clearance K860367
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K860367 for MAGNESIUM (SUBSTRATE, ENZYME, REAGENT), Substantially Equivalent on 1986-04-11. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant: Alpkem Corp.
Product code: Code JGF
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1986-02-03
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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