PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP

Antisera, Fluorescent, Herpesvirus Hominis 1,2

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Pathfinder Detection & Collection Kits-herpes Simp.

Pre-market Notification Details

• Device ID: K852125
• 510k Number: K852125
• Device Name: PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
• Classification: Antisera, Fluorescent, Herpesvirus Hominis 1,2
• Applicant: KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318
• Contact: Diana Salditt
• Correspondent: Diana Salditt; KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318
• Product Code: GQL
• CFR Regulation Number: 866.3305 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-05-15
• Decision Date: 1985-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847865012768	K852125	000
00847865001489	K852125	000
00847865001472	K852125	000
00847865001465	K852125	000
00847865001403	K852125	000
00847865001212	K852125	000