PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

Device Classification Name

calibrators, drug mixture

510(k) Number K033306
Device Name PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Applicant Contact kerwin kaufman
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Correspodent Contact kerwin kaufman
Regulation Number 862.3200
Classification Product Code
DKB  
Date Received 10/14/2003
Decision Date 12/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No