PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K022072
Device Name PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
Original Applicant
PRECISION SYSTEMS, INC.
16 tech circle
natick, 
MA 
01760

Original Contact bill haden
Regulation Number 862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CEK   CEO   CET   CGS  
CGZ   CHH   CIG   CIT   CJE   CKA  
GGY   JFJ   JGJ   JGY   JQB   KHS  
KNK  
Date Received 06/26/2002
Decision Date 08/23/2002
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