PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS

Antiserum, Fluorescent, Chlamydia Trachomatis

KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.

The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Pathfinder(tm) Direct Detection Sys C. Trachomatis.

Pre-market Notification Details

• Device ID: K880031
• 510k Number: K880031
• Device Name: PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
• Classification: Antiserum, Fluorescent, Chlamydia Trachomatis
• Applicant: KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318
• Contact: Quinlan Smith
• Correspondent: Quinlan Smith; KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318
• Product Code: LJP
• CFR Regulation Number: 866.3120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-01-05
• Decision Date: 1988-03-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847865012775	K880031	000
00847865001441	K880031	000
00847865001434	K880031	000
00847865001427	K880031	000
00847865001410	K880031	000