RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST


Device Classification Name

kit, test, pregnancy, hcg, over the counter

510(k) Number K081150
Device Name RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
Applicant
TURKLAB MEDICAL DEVICES INC
10040 sk. ataturk organize
sanayi bolgesi cigli
izmir,, 

TR

35100

Applicant Contact hilda cil
Correspondent
TURKLAB MEDICAL DEVICES INC
10040 sk. ataturk organize
sanayi bolgesi cigli
izmir,, 

TR

35100

Correspodent Contact hilda cil
Regulation Number 862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received 04/23/2008
Decision Date 06/16/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No