Medical Device Manufacturer · US , Des Plaines , IL

Abbott Molecular - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Molecular Microbiology ✕
2 devices
1-2 of 2
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Microbiology · 90d
Cleared Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · QQX
Microbiology · 186d
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