PRECISET DAT PLUS


Device Classification Name

calibrators, drug mixture

510(k) Number K021393
Device Name PRECISET DAT PLUS
Original Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach, 
CA 
90278 -1205

Original Contact gebhard neyer
Regulation Number 862.3200
Classification Product Code
DKB  
Date Received 05/02/2002
Decision Date 06/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No