ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K050305
Device Name ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
Applicant
BIOSCREEN MEDICAL INC.
rr i box 1045a
mildred, 
PA 
18632

Applicant Contact jimmy liang
Correspondent
BIOSCREEN MEDICAL INC.
rr i box 1045a
mildred, 
PA 
18632

Correspodent Contact jimmy liang
Regulation Number 862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received 02/08/2005
Decision Date 05/23/2005
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