510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252484Substantially Equivalent

cobas HCV

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

K252484 is the FDA 510(k) clearance record for cobas HCV, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus). FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming K252484.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation
21 CFR 866.3170
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 MZP

Trailing 12 months
1 clearance under product code MZP in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MZP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260