SERIM LEUKOCYTE ESTERASE TEST STRIPS


Device Classification Name

test, urine leukocyte

510(k) Number K000578
Device Name SERIM LEUKOCYTE ESTERASE TEST STRIPS
Original Applicant
SERIM RESEARCH CORP.
23565 reedy dr.
elkhart, 
IN 
46514

Original Contact robert j carrico
Regulation Number 864.7675
Classification Product Code
LJX  
Date Received 02/22/2000
Decision Date 05/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No