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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K924429
Device Name OPUS(R) CK-MB
Applicant
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact NANC M JOHANSEN
Correspondent
Pb Diagnostic Systems, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact NANC M JOHANSEN
Regulation Number862.1215
Classification Product Code
JHY  
Date Received09/01/1992
Decision Date 10/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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