Medical Device Manufacturer · US , Des Plaines , IL

Abbott Molecular, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2008

Total

Cleared

Denied

Abbott Molecular, Inc. has 16 FDA 510(k) cleared microbiology devices. Based in Des Plaines, US.

Latest FDA clearance: Sep 2025. Active since 2008.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Abbott Molecular, Inc.

17 devices

1-12 of 17

Alinity m EBV (09N43-095)

Alinity m Resp-4-Plex

K241573 · QOF

Microbiology · 256d

Cleared May 03, 2024

Alinity m HSV 1 & 2 / VZV

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....

ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG

K140354 · LSL

Microbiology · 86d

Cleared Sep 13, 2013

VYSIS D7S486/CEP 7 FISH PROBE KIT

K131508 · PFG

Pathology · 112d

Not Cleared Jul 29, 2013

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

DEN130010 · PDO

Pathology · 111d

Abbott Molecular, Inc. - FDA 510(k) Cleared Devices

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