LIFEGUARD


Device Classification Name

reagent, occult blood

510(k) Number K022755
Device Name LIFEGUARD
Original Applicant
MEDTEK LLC.
10315b chapel hill rd.
morrisville, 
NC 
27560

Original Contact deborah n ballard
Regulation Number 864.6550
Classification Product Code
KHE  
Date Received 08/20/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No