510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261336Substantially Equivalent

Xpert Respiratory Panel

Cepheid, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(155 days to decision)
Product code
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Regulation
21 CFR 866.3981
Device class
Class II
Review panel
Microbiology
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QOF

Trailing 12 months
7 clearances under product code QOF in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code QOF, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20263
October 20260