ACON Laboratories, Inc.
Distinct® Early Detection Pregnancy Test
SKU K193318UPC LCX
In Stock
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IIFDA 510(k) Cleared (K193318)
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Free shipping on orders over $99 · 30-day returns
ACON Laboratories, Inc.
Free shipping on orders over $99 · 30-day returns
Distinct® Early Detection Pregnancy Test is an FDA 510(k)-cleared medical device (K193318) manufactured by ACON Laboratories, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2020. Regulation: 8.
