LIFEGUARD

Reagent, Occult Blood

MEDTEK LLC.

The following data is part of a premarket notification filed by Medtek Llc. with the FDA for Lifeguard.

Pre-market Notification Details

• Device ID: K022755
• 510k Number: K022755
• Device Name: LIFEGUARD
• Classification: Reagent, Occult Blood
• Applicant: MEDTEK LLC. 10315B CHAPEL HILL RD. Morrisville, NC 27560
• Contact: Deborah N Ballard
• Correspondent: Deborah N Ballard; MEDTEK LLC. 10315B CHAPEL HILL RD. Morrisville, NC 27560
• Product Code: KHE
• CFR Regulation Number: 864.6550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-08-20
• Decision Date: 2002-09-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20722355002747	K022755	000