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PRJ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Capillary Blood Collection Device For Alternative Site Collection
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Medical specialty
Clinical Chemistry
FDA definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
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RecordFirmDate
TAP Blood Collection Device (K190225)Seventh Sense Biosystems, Inc.2019-11-05
TAP Blood Collection Device (K161521)Seventh Sense Biosystems, Inc.2017-02-16

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