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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K920207
Device Name HERMLE Z230H
Applicant
Labnet Intl., Inc.
P.O. Box 841
Woodbridge,  NJ  07095
Applicant Contact WALTER DEMSIA
Correspondent
Labnet Intl., Inc.
P.O. Box 841
Woodbridge,  NJ  07095
Correspondent Contact WALTER DEMSIA
Regulation Number864.6400
Classification Product Code
GKG  
Date Received01/16/1992
Decision Date 06/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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