CALCIUM

Cresolphthalein Complexone, Calcium

DILAB, INC.

The following data is part of a premarket notification filed by Dilab, Inc. with the FDA for Calcium.

Pre-market Notification Details

• Device ID: K850929
• 510k Number: K850929
• Device Name: CALCIUM
• Classification: Cresolphthalein Complexone, Calcium
• Applicant: DILAB, INC. 7003 N.W. 50TH ST. Miami, FL 33166
• Contact: Rafael A Quevedo
• Correspondent: Rafael A Quevedo; DILAB, INC. 7003 N.W. 50TH ST. Miami, FL 33166
• Product Code: CIC
• CFR Regulation Number: 862.1145 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-03-07
• Decision Date: 1985-06-10