MAGNESIUM

Photometric Method, Magnesium

DERMA MEDIA LAB., INC.

The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Magnesium.

Pre-market Notification Details

• Device ID: K964915
• 510k Number: K964915
• Device Name: MAGNESIUM
• Classification: Photometric Method, Magnesium
• Applicant: DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670
• Contact: Charles C Allain, Ph.d.
• Correspondent: Charles C Allain, Ph.d.; DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670
• Product Code: JGJ
• CFR Regulation Number: 862.1495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-09
• Decision Date: 1997-03-26