510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203220Substantially Equivalent

cobas BKV

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

K203220 is the FDA 510(k) clearance record for cobas BKV, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna). FDA's definition for product code QLX reads: "A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming K203220.

Clearance record

Decision date
Received
(88 days to decision)
Product code
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Regulation
21 CFR 866.3183
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 QLX

Trailing 12 months

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

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