MSI-NAK-50 Test Kit

FDA 510(k) K831300 · Medical Specialties, Inc.

Substantially Equivalent

510(k) numberK831300

Submission

Device name
MSI-NAK-50 Test Kit
Applicant
Medical Specialties, Inc.
Mchenry, IL, US
Received
April 21, 1983
Decision date
July 18, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JGM – Flame Photometry, Potassium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1600
Specialty
Clinical Chemistry

Other 510(k)s with product code JGM

510(k)DeviceApplicantDecision
K895718Lithium Concentrate for a Flame PhotometerJGM · Traditional Data Medical Associates, Inc.10/19/1989SE
K862300Amresco Flow Pac Sodium Potassium ReagentJGM · Traditional Amresco, Inc.07/29/1986SE
K810253Sodium & Potassium Test KitJGM · Traditional Mallinckrodt Critical Care02/10/1981SE
K771068Triglyceride KitJGM · Traditional Environmental Chemical Specialties07/12/1977SE

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Questions and answers

When was MSI-NAK-50 Test Kit cleared by the FDA?

MSI-NAK-50 Test Kit (K831300) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 88 days after the submission was received.

What is the product code of K831300?

The FDA product code is JGM – Flame Photometry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.