CALCIUM

Cresolphthalein Complexone, Calcium

CATACHEM, INC.

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

Pre-market Notification Details

• Device ID: K880308
• 510k Number: K880308
• Device Name: CALCIUM
• Classification: Cresolphthalein Complexone, Calcium
• Applicant: CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573
• Contact: Luis P Leon
• Correspondent: Luis P Leon; CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573
• Product Code: CIC
• CFR Regulation Number: 862.1145 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-01-25
• Decision Date: 1988-05-27