CULUTURE SET CHLAMYDIA ISOLATION AND

Antisera, Fluorescent, Chlamydia Spp.

IMMULOK, INC.

The following data is part of a premarket notification filed by Immulok, Inc. with the FDA for Culuture Set Chlamydia Isolation And.

Pre-market Notification Details

• Device ID: K830342
• 510k Number: K830342
• Device Name: CULUTURE SET CHLAMYDIA ISOLATION AND
• Classification: Antisera, Fluorescent, Chlamydia Spp.
• Applicant: IMMULOK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LKI
• CFR Regulation Number: 866.3120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-02-01
• Decision Date: 1983-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840733101205	K830342	000