PREG-Q EARLY PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K023027
Device Name PREG-Q EARLY PREGNANCY TEST
Original Applicant
YD DIAGNOSTICS
962 allegro ln.
apollo beach, 
FL 
33572

Original Contact art beach
Regulation Number 862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received 09/11/2002
Decision Date 12/16/2002
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