LO-ION

Media, Potentiating For In Vitro Diagnostic Use

GAMMA BIOLOGICALS, INC.

The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Lo-ion.

Pre-market Notification Details

• Device ID: K790973
• 510k Number: K790973
• Device Name: LO-ION
• Classification: Media, Potentiating For In Vitro Diagnostic Use
• Applicant: GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KSG
• CFR Regulation Number: 864.9600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-05-23
• Decision Date: 1979-06-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234001775	K790973	000