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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All, Mycoplasma Spp.
510(k) Number K861716
Device Name FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact LOUISE M HARRIS
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact LOUISE M HARRIS
Regulation Number866.3375
Classification Product Code
GRZ  
Date Received05/06/1986
Decision Date 08/08/1986
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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