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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
Date
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impact model 308 Impact Instrumentation, Inc. k841538 06/11/1984
optimate iga test Miles Laboratories, Inc. k841815 06/01/1984
fiax transferrin test kit Intl. Diagnostic Technology k842071 07/11/1984
amer. histo-id sys primary igm s7920-31 Bartels Immunodiagnostic Supplies, Inc. k842327 08/02/1984
rapid plasma reagin card test Clinical Sciences, Inc. k842541 07/26/1984
sunbed Sun Health Systems k842787 08/15/1984
command enamel-dent dental adhesive Kerr Corporation (Danbury) k843025 10/25/1984
alkaline phosphatase reagent set Sterling Biochemical, Inc. k843332 09/14/1984
scanheads-access 10pv, biostatic Advanced Technology Laboratories, Inc. k843620 03/12/1985
h. simplex virus Institute Virion , Ltd. k843658 09/26/1985

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