BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER


codes

Device Classification Name

electrode, ion specific, sodium

510(k) Number K002855
Device Name BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
Original Applicant
BIOCARE CORP.
200 prospect st.
waltham, 
MA 
02454

Original Contact paul w mcdonald
Regulation Number 862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JIH  
Date Received 09/13/2000
Decision Date 10/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No