MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)— 510(k) K202423

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K202423 for MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL), Substantially Equivalent on 2021-05-18. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JWY
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Sacramento, CA, US
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