510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010891Substantially Equivalent

Modification to Hybrid Capture II Ct/gc Test, Model 03M90-01

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

K010891 is the FDA 510(k) clearance record for MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01, a class I device, cleared for Digene Corp. on under FDA product code LSK (Dna-Reagents, Chlamydia). FDA records list 26 510(k) clearances for QIAGEN, from to . As of , FDA records show no recalls naming K010891.

Clearance record

Decision date
Received
(183 days to decision)
Product code
LSK Dna-Reagents, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Digene Corp. 1201 Clopper Rd., Gaithersburg MD
510(k) summary
Summary
Third party review
No

Clearances, product code LSK

Trailing 12 months

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

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