OPUS CK-MB & TOTAL CK CONTROLS


Device Classification Name

enzyme controls (assayed and unassayed)

510(k) Number K960275
Device Name OPUS CK-MB & TOTAL CK CONTROLS
Applicant
BEHRING DIAGNOSTICS, INC.
151 university ave.
westwood, 
MA 
02090

Applicant Contact nancy m joansen
Correspondent
BEHRING DIAGNOSTICS, INC.
151 university ave.
westwood, 
MA 
02090

Correspodent Contact nancy m joansen
Regulation Number 862.1660
Classification Product Code
JJT  
Date Received 01/19/1996
Decision Date 04/25/1996
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