510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053289Substantially Equivalent

Cobas Amplicor Ct/ng Test for Neisseria Gonorrhoeae

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053289 is the FDA 510(k) clearance record for COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code LSL (Dna-Reagents, Neisseria). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K053289.

Clearance record

Decision date
Received
(258 days to decision)
Product code
LSL Dna-Reagents, Neisseria
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSL

Trailing 12 months

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

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