Xpert Xpress Strep A— 510(k) K172126
Substantially EquivalentCepheid
FDA 510(k) clearance K172126 for Xpert Xpress Strep A, Substantially Equivalent on 2017-09-25. Applicant: Cepheid. Device class: 2.
Clearance details
- Applicant
- Cepheid
- Product code
- Code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code PGX
view all- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
- K201269 — Accula Strep A Test
- K183366 — GenePOC Strep A
- K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
More clearances from Cepheid
view allRecalls naming K172126
K-number listed on FDA's recall record- Z-0215-2024 — Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
- Z-0216-2024 — Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172126.
Data sourced from openFDA. This site is unofficial and independent of the FDA.