510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222558Substantially Equivalent

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Centers for Disease Control and Prevention, Atlanta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222558 is the FDA 510(k) clearance record for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set). FDA's definition for product code PBK reads: "In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming K222558.

Clearance record

Decision date
Received
(6 days to decision)
Product code
PBK Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Regulation
21 CFR 866.3315
Device class
Class II
Review panel
Microbiology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd. NE, Ms-H24-11, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBK

Trailing 12 months

FDA records hold no clearances under product code PBK in the trailing twelve months.

FDA records show no clearances under product code PBK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PBK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260