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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chromatography (Liquid, Gel), Clinical Use
510(k) Number K851945
Device Name VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
Applicant
Varian Assoc., Inc.
611 Hansen Way
P.O. Box 10800
Palo Alto,  CA  94303
Applicant Contact MILTON D DIEGEL
Correspondent
Varian Assoc., Inc.
611 Hansen Way
P.O. Box 10800
Palo Alto,  CA  94303
Correspondent Contact MILTON D DIEGEL
Regulation Number862.2260
Classification Product Code
KZR  
Date Received05/03/1985
Decision Date 05/24/1985
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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