510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974901Substantially Equivalent

Hybrid Capture System Cmv DNA Assay

Qiagen, Beltsville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974901 is the FDA 510(k) clearance record for HYBRID CAPTURE SYSTEM CMV DNA ASSAY, a class II device, cleared for Digene Corp. on under FDA product code LJO (Antigen, Iha, Cytomegalovirus). FDA records list 26 510(k) clearances for QIAGEN, from to . As of , FDA records show no recalls naming K974901.

Clearance record

Decision date
Received
(272 days to decision)
Product code
LJO Antigen, Iha, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Digene Corp. 9000 Virginia Manor Rd.,, Beltsville MD
510(k) summary
Summary
Third party review
No

Clearances, product code LJO

Trailing 12 months

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

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