K202423 is an FDA 510(k) clearance for the MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL). This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on May 18, 2021, 266 days after receiving the submission on August 25, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K202423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2020 |
| Decision Date | May 18, 2021 |
| Days to Decision | 266 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |