AT HOME OVULATION TEST, MODEL 9032


Device Classification Name

radioimmunoassay, luteinizing hormone

510(k) Number K021409
Device Name AT HOME OVULATION TEST, MODEL 9032
Original Applicant
PHAMATECH INC.
9530 padgett st., #101-106
san diego, 
CA 
92126

Original Contact carl a mongiovi
Regulation Number 862.1485
Classification Product Code
CEP  
Date Received 05/03/2002
Decision Date 05/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No