PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS


Device Classification Name

urease and glutamic dehydrogenase, urea nitrogen

510(k) Number K024182
Device Name PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
Original Applicant
PRECISION SYSTEMS, INC.
16 tech circle
natick, 
MA 
01760

Original Contact bill haden
Regulation Number 862.1770
Classification Product Code
CDQ  
Subsequent Product Codes
CEO   CGA   CGS   CGX   CHH  
CHJ   CIG   CIT   CIX   CJE   CJY  
JGJ   JGY   JJF   KNK  
Date Received 12/19/2002
Decision Date 03/03/2003
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