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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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