Helena Laboratories, Corp.
SPIFE A1AT kit
SKU K213396UPC OBZ
In Stock
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IIFDA 510(k) Cleared (K213396)
1
Free shipping on orders over $99 · 30-day returns
Helena Laboratories, Corp.
Free shipping on orders over $99 · 30-day returns
SPIFE A1AT kit is an FDA 510(k)-cleared medical device (K213396) manufactured by Helena Laboratories, Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2022. Regulation: 8.
