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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Columns, Liquid Chromatography
510(k) Number K952501
Device Name TOX PERFECT B TUBES AND REAGENTS
Applicant
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Applicant Contact CHARLES A HAY
Correspondent
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Correspondent Contact CHARLES A HAY
Regulation Number862.2260
Classification Product Code
DPM  
Date Received05/30/1995
Decision Date 08/24/1995
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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