STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT


Device Classification Name

21-hydroxylase antibody (21-ohab)

510(k) Number K121046
Device Name STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 s. seneca springs way
suite 105
star, 
ID 
83669

Applicant Contact heather viele
Correspondent
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 s. seneca springs way
suite 105
star, 
ID 
83669

Correspodent Contact heather viele
Regulation Number 866.5660
Classification Product Code
PCG  
Date Received 04/06/2012
Decision Date 12/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No