510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172287Substantially Equivalent

ipsogen JAK2 RGQ PCR Kit

Qiagen, Germantown MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172287 is the FDA 510(k) clearance record for ipsogen JAK2 RGQ PCR Kit, a class II device, cleared for Qiagen, Inc. on under FDA product code PSU (Jak2 Gene Mutation Detection Test). FDA's definition for product code PSU reads: "The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological...". FDA records list 26 510(k) clearances for Qiagen, Inc., from to . As of , FDA records show no recalls naming K172287.

Clearance record

Decision date
Received
(168 days to decision)
Product code
PSU Jak2 Gene Mutation Detection Test
Regulation
21 CFR 866.6070
Device class
Class II
Review panel
Medical Genetics
Applicant
Qiagen, Inc. 19300 Germantown Rd., Germantown MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSU

Trailing 12 months

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

FDA records show no clearances under product code PSU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSU, 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