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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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ames sera-pak hemoglobin reagent MILES LABORATORIES, INC. k803248 01/26/1981
photometer TURNER DESIGNS, INC. k803285 01/16/1981
cytotran i bone marrow aspiration system APPLIED MEDICAL DEVICES, INC. k802406 01/15/1981
raytheon medical imaging MACHLETT LABORATORIES, INC. k802888 01/09/1981
vista 54 liquid chromatography anal. sys VARIAN ASSOC., INC. k802725 12/11/1980
telesonic, arcon & soundex asp 102 TELESONIC, INC. k802596 11/12/1980
uric acid diagnostic reagent CONNECTICUT DIAGNOSTICS, LTD. k801898 10/10/1980
3m hi-strength med. tape #1534 3M COMPANY k802242 09/26/1980
aria ii 125- i-estriol system BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC k801735 09/16/1980
catheter insertion tray WALPAK CO. k802083 09/16/1980

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