LIQUID CARDIAC MARKER 1,2,3 ASSAYED


Device Classification Name

enzyme controls (assayed and unassayed)

510(k) Number K960246
Device Name LIQUID CARDIAC MARKER 1,2,3 ASSAYED
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 coney st.
e. walpole, 
MA 
02032

Applicant Contact ronald d schaefer
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 coney st.
e. walpole, 
MA 
02032

Correspodent Contact ronald d schaefer
Regulation Number 862.1660
Classification Product Code
JJT  
Date Received 01/16/1996
Decision Date 04/23/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized