Medical Device Manufacturer · US , Salem , NH

ALPCO - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2019
2
Total
2
Cleared
0
Denied

ALPCO has 2 FDA 510(k) cleared medical devices. Based in Salem, US.

Last cleared in 2023. Active since 2019. Primary specialty: Immunology.

Browse the FDA 510(k) cleared devices submitted by ALPCO Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Diazyme Laboratories, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - ALPCO

2 devices
1-2 of 2
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · NXO
Immunology · 393d
Cleared Oct 25, 2019
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · NXO
Immunology · 112d
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