Test, Residual, WBC In Leukoreduced Blood

Test, Residual, Wbc In Leukoreduced Blood

Nanoentek, Inc.

The following data is part of a premarket notification filed by Nanoentek, Inc. with the FDA for Test, Residual, Wbc In Leukoreduced Blood.

Pre-market Notification Details

Device IDBK210621
510k NumberBK210621
Device Name:Test, Residual, WBC In Leukoreduced Blood
ClassificationTest, Residual, Wbc In Leukoreduced Blood
Applicant Nanoentek, Inc. nanoentek, Inc. 851-14 Seohae-ro, Paltan-myeon 09  Hwaseong-si,  18531,  KOREA, SOUTH
Product CodeMZG  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2021-10-28

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