KRONUS OPTIQUANT THYROGLOBULIN KIT


Device Classification Name

system,test,thyroglobulin

510(k) Number K991720
Device Name KRONUS OPTIQUANT THYROGLOBULIN KIT
Applicant
UNCHANGED
1000 calle amanecer
san clemente, 
CA 
92673

Applicant Contact a.p. doerscchuk
Correspondent
UNCHANGED
1000 calle amanecer
san clemente, 
CA 
92673

Correspodent Contact a.p. doerscchuk
Regulation Number 866.6010
Classification Product Code
MSW  
Date Received 05/20/1999
Decision Date 08/09/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Immunology

510k Review Panel

Immunology
statement

statement

Type Traditional
Reviewed by Third Party No
Combination Product

No