ESA BIOSCIENCES INC. VITAMIN D HPLC TEST


Device Classification Name

system, test, vitamin d

510(k) Number K072536
Device Name ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
Applicant
ESA BIOSCIENCES INC.
22 alpha rd.
chelmsford, 
MA 
01824 -4171

Applicant Contact harold asp
Correspondent
ESA BIOSCIENCES INC.
22 alpha rd.
chelmsford, 
MA 
01824 -4171

Correspodent Contact harold asp
Regulation Number 862.1825
Classification Product Code
MRG  
Date Received 09/07/2007
Decision Date 05/07/2008
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