FDA Product Code
FDA Product Code PAB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3180
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252481 | cobas CMV | Roche Molecular Systems, Inc. | 2025-11-03 | Traditional | PDF ↗ |
| K243485 | Alinity m CMV | Abbott Molecular, Inc. | 2025-07-01 | Traditional | PDF ↗ |
| K243935 | Aptima CMV Quant Assay | Hologic, Inc. | 2025-01-17 | Special | PDF ↗ |
Product code PAB · Class II · Microbiology. Data: openFDA.