Xpert MRSA/SA SSTI— 510(k) K243625

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243625 for Xpert MRSA/SA SSTI, Substantially Equivalent on 2024-12-18. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2024-11-25
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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