
Beckman Coulter, Inc.
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MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) is an FDA 510(k)-cleared medical device (K250084) manufactured by Beckman Coulter, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2025. Regulation: 8.

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