510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K110923Substantially Equivalent

Cobas 4800 CT / Ng Test

Roche Molecular Systems Inc, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110923 is the FDA 510(k) clearance record for COBAS 4800 CT / NG TEST, a class I device, cleared for Roche Molecular Systems, Inc. on under FDA product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia). FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show 2 recalls naming K110923.

Clearance record

Decision date
Received
(298 days to decision)
Product code
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Roche Molecular Systems, Inc. 4300 Hacienda Dr., Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MKZ

Trailing 12 months

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

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