CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX

Media And Components, Synthetic Cell And Tissue Culture

BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.

The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Chlamydiae Isolation Medium W/cyclohex.

Pre-market Notification Details

• Device ID: K834122
• 510k Number: K834122
• Device Name: CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
• Classification: Media And Components, Synthetic Cell And Tissue Culture
• Applicant: BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KIT
• CFR Regulation Number: 864.2220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-29
• Decision Date: 1984-02-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516747363	K834122	000
05391516747356	K834122	000