510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223783Substantially Equivalent

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

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

K223783 is the FDA 510(k) clearance record for cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code QWR (Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings). FDA's definition for product code QWR reads: "A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming K223783.

Clearance record

Decision date
Received
(353 days to decision)
Product code
QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Regulation
21 CFR 866.3982
Device class
Class II
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 QWR

Trailing 12 months

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

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