Set, Transfer (Blood/Plasma)

Set, Transfer (blood/plasma)

GenesisBPS, LLC

The following data is part of a premarket notification filed by Genesisbps, Llc with the FDA for Set, Transfer (blood/plasma).

Pre-market Notification Details

Device IDBK210584
510k NumberBK210584
Device Name:Set, Transfer (Blood/Plasma)
ClassificationSet, Transfer (blood/plasma)
Applicant GenesisBPS, LLC 465 State Route 17 Ramsey,  NJ  07446
Product CodeKSB  
CFR Regulation Number864.9875 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-22
Decision Date2022-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00866305000264 BK210584 0

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