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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K896202
Device Name MATRIX(TM)-96
Applicant
Canberra Industries, Inc.
One State St.
Meriden,  CT  06450
Applicant Contact JAMES T CERRETO
Correspondent
Canberra Industries, Inc.
One State St.
Meriden,  CT  06450
Correspondent Contact JAMES T CERRETO
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received10/26/1989
Decision Date 01/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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