CALCIUM

Azo Dye, Calcium

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Calcium.

Pre-market Notification Details

• Device ID: K062855
• 510k Number: K062855
• Device Name: CALCIUM
• Classification: Azo Dye, Calcium
• Applicant: ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038
• Contact: Linda Morris
• Correspondent: Linda Morris; ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038
• Product Code: CJY
• CFR Regulation Number: 862.1145 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-25
• Decision Date: 2006-11-22
• Summary: summary