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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K896373
Device Name 1400 SERIES EVIDENCE COLLECTION KIT
Applicant
Transidyne General Corp.
3711 Plz. Dr., #4
Ann Arbor,  MI  48108
Applicant Contact MARGARET K BEAUDET
Correspondent
Transidyne General Corp.
3711 Plz. Dr., #4
Ann Arbor,  MI  48108
Correspondent Contact MARGARET K BEAUDET
Regulation Number862.1675
Classification Product Code
GIM  
Date Received11/06/1989
Decision Date 02/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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