EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)


Device Classification Name

radioimmunoassay, luteinizing hormone

510(k) Number K991386
Device Name EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
Applicant
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Applicant Contact carol adiletto
Correspondent
SELFCARE, INC.
200 prospect st.
waltham, 
MA 
02154 -3457

Correspodent Contact carol adiletto
Regulation Number 862.1485
Classification Product Code
CEP  
Date Received 04/21/1999
Decision Date 05/25/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No