FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS


Device Classification Name

visual, pregnancy hcg, prescription use

510(k) Number K112101
Device Name FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
Applicant
POLYMED THERAPEUTICS, INC
27001 la paz road,
suite 266b
mission viejo, 
CA 
92691

Applicant Contact terri wallace
Correspondent
POLYMED THERAPEUTICS, INC
27001 la paz road,
suite 266b
mission viejo, 
CA 
92691

Correspodent Contact terri wallace
Regulation Number 862.1155
Classification Product Code
JHI  
Date Received 07/22/2011
Decision Date 07/17/2012
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