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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
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chlamydiae immunoperoxidase test kit Bartels Immunodiagnostic Supplies, Inc. k842151 07/20/1984
levine eosin methylene blue agar The Montana Deaconess Medical Center k841751 05/31/1984
burn bath Setma, Inc. k841397 05/18/1984
betaject bd u100 Orange Medical Instruments, Inc. k833705 05/09/1984
fiber hemofilters fh55-fh77 & 88 Gambro, Inc. k840720 04/24/1984
durazyme cholesterol American Monitor Corp. k840368 03/30/1984
endix radicular bioceramic pin C.B.S. Biotechnics, Inc. k834363 02/27/1984
chocolate agar gc base plate Otisville Biotech, Inc. k840065 02/13/1984
alpha y-recipient set Alpha Therapeutic Corp. k833294 12/27/1983
neuroflax, epk Franks Electronics k831990 11/28/1983

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