Blood Bank Supplies

Supplies, Blood-bank

Typenex Medical LLC

The following data is part of a premarket notification filed by Typenex Medical Llc with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK150351
510k NumberBK150351
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Typenex Medical LLC 303 East Wacker Drive suite 311 Chicago,  IL  60601
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-04
Decision Date2015-12-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812269031264 BK150351 0
00812269031240 BK150351 0

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