INSTANT-VIEW LH OVULATION PREDICTING TEST


Device Classification Name

radioimmunoassay, luteinizing hormone

510(k) Number K022829
Device Name INSTANT-VIEW LH OVULATION PREDICTING TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 862.1485
Classification Product Code
CEP  
Date Received 08/26/2002
Decision Date 11/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No