CHLORIDE

Coulometric, Chloride

GAMMA ENTERPRISES, INC.

The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Chloride.

Pre-market Notification Details

• Device ID: K771832
• 510k Number: K771832
• Device Name: CHLORIDE
• Classification: Coulometric, Chloride
• Applicant: GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JFS
• CFR Regulation Number: 862.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-09-21
• Decision Date: 1977-11-22