FDA Product Code
FDA Product Code OMM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7280
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100987 | INVADER MTHFR 677 | Hologic, Inc. | 2011-05-13 | Traditional | PDF ↗ |
| K100496 | INVADER MTHFR 1298 | Hologic, Inc. | 2011-04-25 | Traditional | PDF ↗ |
Product code OMM · Class II · Hematology. Data: openFDA.