510(k) K241921
- Device
- Alinity m BKV
- Applicant
- Abbott Molecular, Inc.
- 510(k) number
- K241921
- Product code
- QMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-24
- Date received
- 2024-07-01
- Regulation
- 866.3183
- Classification name
- Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gina Sammarco
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 2243471
- 3004141078
- 3005248192
- 3019837962
- 3003795116
Source Documents#
Other 510(k) Records For Product Code QMI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020-09-02 |