Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit

FDA 510(k) K972591 · Morax

Substantially Equivalent

510(k) numberK972591

Submission

Device name
Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit
Applicant
Morax
Chelsea, MI, US
Received
July 11, 1997
Decision date
March 4, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JKM – Immunochemical, Bence-Jones Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5150
Specialty
Immunology

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K050119Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…JKM · Traditional Beckman Coulter, Inc.05/06/2005SE

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Questions and answers

When was Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit cleared by the FDA?

Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit (K972591) received a 510(k) decision of Substantially Equivalent on March 4, 1998, 236 days after the submission was received.

What is the product code of K972591?

The FDA product code is JKM – Immunochemical, Bence-Jones Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5150.