LOQ — Device, General Purpose, Hematology Class II
FDA product code LOQ covers "Device, General Purpose, Hematology", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LOQ
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981592 | chiron diagnostics | ACS:CENTAUR AFP | July 7, 1998 |