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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Microtiter Diluting/Dispensing
510(k) Number K844552
Device Name BIO-STAT III PLATE WASHER
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact PATRICIA B SHADER
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact PATRICIA B SHADER
Regulation Number866.2500
Classification Product Code
JTC  
Date Received11/21/1984
Decision Date 01/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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