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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aggregrometer, Platelet
510(k) Number K881829
Device Name PAT PLATELET AGGREGATION TEST
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact HALVOR SORNSON
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact HALVOR SORNSON
Regulation Number864.6675
Classification Product Code
JBX  
Date Received04/29/1988
Decision Date 07/01/1988
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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