ACCESS HYPERSENSITIVE HTSH ASSAY


Device Classification Name

radioimmunoassay, thyroid-stimulating hormone

510(k) Number K023093
Device Name ACCESS HYPERSENSITIVE HTSH ASSAY
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Original Contact denise thompson
Regulation Number 862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received 09/18/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No