Access Syphilis— 510(k) K241427

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K241427 for Access Syphilis, Substantially Equivalent on 2024-09-06. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LIP
Advisory panel: Microbiology
Date received: 2024-05-20
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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