ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

System, Test, Vitamin D

BIOKIT S.A.

The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect 25-oh Vitamin D 100t, Vitamin D 500t, Vitamin D Calibrators, Vitamin D Controls.

Pre-market Notification Details

• Device ID: K110619
• 510k Number: K110619
• Device Name: ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
• Classification: System, Test, Vitamin D
• Applicant: BIOKIT S.A. CAN MALE, S/N Llissa D'amunt, Barcelona, ES 08186
• Contact: Joan Guixer
• Correspondent: Joan Guixer; BIOKIT S.A. CAN MALE, S/N Llissa D'amunt, Barcelona, ES 08186
• Product Code: MRG
• Subsequent Product Code: JIT
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1825 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-03
• Decision Date: 2011-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740082147	K110619	000
00380740082130	K110619	000
00380740082123	K110619	000
00380740082116	K110619	000