IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K110889
Device Name IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
Applicant
IND DIAGNOSTICS INC.
1629 fosters way
delta, british columbia, 

CA

v3m 6s7

Applicant Contact kai lou
Correspondent
IND DIAGNOSTICS INC.
1629 fosters way
delta, british columbia, 

CA

v3m 6s7

Correspodent Contact kai lou
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 03/30/2011
Decision Date 06/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No