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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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Applicant
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510(K)
Number
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Decision
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amer. histo-id sys primary igm s7920-31 Bartels Immunodiagnostic Supplies, Inc. k842327 08/02/1984
sunbed Sun Health Systems k842787 08/15/1984
alkaline phosphatase reagent set Sterling Biochemical, Inc. k843332 09/14/1984
phenylethyl alcohol agar plate Otisville Biotech, Inc. k834422 10/23/1984
command enamel-dent dental adhesive Kerr Corporation (Danbury) k843025 10/25/1984
mobilimb hand unit Danninger Medical Technology, Inc. k844033 11/27/1984
renaissance bonding agent Williams Gold Refining Co., Inc. k844394 01/09/1985
models 134, 135 & 136 transfer cart/table Tri W-G, Inc. k844711 03/05/1985
leucine aminopeptidase reagent Alladin Diagnostic, Inc. k844965 03/05/1985
rpmi-1603 medium Hazleton Research Products, Inc. k850229 03/05/1985

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