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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer
510(k) Number K863434
Device Name THE FIAX 5000 FLUOROMETER
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact PATRICIA B SHRADER
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact PATRICIA B SHRADER
Regulation Number866.4520
Classification Product Code
JZT  
Date Received09/04/1986
Decision Date 10/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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