FDA 510(k) Applications Submitted by Helena Laboratories, Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K192931 10/17/2019 V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control Helena Laboratories, Corp.
K213396 10/18/2021 SPIFE A1AT kit Helena Laboratories, Corp.


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