DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA

System, Test, Vitamin D

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme 25-hydroxy Vitamin D Eia Kit Diazyme 25-hydroxy Vitamin D Eia Control Set Dia.

Pre-market Notification Details

• Device ID: K122420
• 510k Number: K122420
• Device Name: DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
• Classification: System, Test, Vitamin D
• Applicant: DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064
• Contact: Abhijit Datta
• Correspondent: Abhijit Datta; DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064
• Product Code: MRG
• CFR Regulation Number: 862.1825 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-09
• Decision Date: 2012-11-28
• Summary: summary