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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K811036
Device Name FILTER SAMPLER BLOOD SERUM FILTER
Applicant
Glasrock Plastics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Glasrock Plastics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/16/1981
Decision Date 04/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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