CASSETTE/URINE HCG


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K023638
Device Name CASSETTE/URINE HCG
Original Applicant
IND DIAGNOSTIC INC.
1629 fosters way
delta, bc, 

CA

v3m 6s7

Original Contact david lee
Regulation Number 862.1155
Classification Product Code
LCX  
Date Received 10/30/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No