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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer
510(k) Number K882677
Device Name STAT-20 FLUOROMETER
Applicant
Weaver Medical
3165 W. 4700 S.
Salt Lake City,  UT  84118
Applicant Contact WEAVER, D.D.S.
Correspondent
Weaver Medical
3165 W. 4700 S.
Salt Lake City,  UT  84118
Correspondent Contact WEAVER, D.D.S.
Regulation Number866.4520
Classification Product Code
JZT  
Date Received06/28/1988
Decision Date 07/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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