510(k) K252481
- Device
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
- 510(k) number
- K252481
- Product code
- PAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-03
- Date received
- 2025-08-07
- Regulation
- 866.3180
- Classification name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sun Austin
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 2243471
- 3004141078
- 9610126
- 2024800
- 3005248192
- 3019837962
- 3025663244
- 2023365
- 3004013603
- 3003795116