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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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follicle stimulating hormone (hfsh) Immuchem Corp. k871317 05/20/1987
u. v. germicidal unit Lorvic Corp. k871615 09/11/1987
the uric acid reagent set Macomb Biotechnology, Inc. k871902 06/03/1987
lectec stimulating electrode Lectec Corp. k872250 08/07/1987
prothrombin time test Sclavo, Inc. k872537 08/27/1987
vinyl polysiloxane impression system Crown Delta Corp. k872745 07/21/1987
tryptic soy agar (tsa) slant - product #t8765 11ml Lakewood Biochemical Co., Inc. k873059 08/24/1987
medix biotech prolactin enzyme immuno. test kit Medix Biotech, Inc. k873355 10/09/1987
chemelia enzyme immunoassay for (tsh) Boots-Celltech Diagnostics, Inc. k873625 10/20/1987
the extractor(tm) Molecular Biosystems, Inc. k873932 11/20/1987

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