EARLYDETECT MENOPAUSE TEST FOR FSH


Device Classification Name

radioimmunoassay, follicle-stimulating hormone

510(k) Number K030058
Device Name EARLYDETECT MENOPAUSE TEST FOR FSH
Original Applicant
EARLY DETECT, INC.
2950 north glassell st.
orange, 
CA 
92865

Original Contact peter george
Regulation Number 862.1300
Classification Product Code
CGJ  
Date Received 01/07/2003
Decision Date 07/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No