ST AIA-PACK DHEA-S CALIBRATOR SET


Device Classification Name

calibrator, secondary

510(k) Number K111762
Device Name ST AIA-PACK DHEA-S CALIBRATOR SET
Applicant
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Applicant Contact judith k ogden
Correspondent
Tosoh BioScience, Inc.
6000 shoreline court
suite 101
south san francisco, 
CA 
94080

Correspodent Contact judith k ogden
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 06/23/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No