510(k) K202423

MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) by Beckman Coulter, Inc. — Product Code JWY

K202423 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)". The FDA issued a decision of Substantially Equivalent on May 18, 2021. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Beckman Coulter, Inc. has 277 other 510(k) clearances on record.