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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 K922445
Device Name VACU-PRO
Applicant
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/22/1992
Decision Date 08/12/1992
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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