510(k) K203220
- Device
- Cobas BKV
- Applicant
- Roche Molecular Systems, Inc.
- 510(k) number
- K203220
- Product code
- QLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-29
- Date received
- 2020-11-02
- Regulation
- 866.3183
- Classification name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Raji Grewal
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 2243471
- 3004141078
- 9610126
- 3005248192
- 3025663244
- 2023365
- 3003795116
Source Documents#
Other 510(k) Records For Product Code QLX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025-07-28 |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | Abbott Molecular, Inc. | 2022-07-15 |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020-07-30 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases