STAT PROFILE M7 ANALYZER


Device Classification Name

electrode, ion based, enzymatic, creatinine

510(k) Number K991727
Device Name STAT PROFILE M7 ANALYZER
Applicant
NOVA BIOMEDICAL CORP.
200 prospect st.
waltham, 
MA 
02454 -9141

Applicant Contact paul w macdonald
Correspondent
NOVA BIOMEDICAL CORP.
200 prospect st.
waltham, 
MA 
02454 -9141

Correspodent Contact paul w macdonald
Regulation Number 862.1225
Classification Product Code
CGL  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   CHL  
GLY   JFP   JGS   JKS   JPI   KHP  
Date Received 05/20/1999
Decision Date 07/16/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No