GJR — Control, Red-Cell Class II
FDA product code GJR covers "Control, Red-Cell", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GJR
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K080016 | streck | NRBC-CHEX FOR ADVIA | February 5, 2008 |
| K060083 | streck | NRBC-CHEX FOR LH | February 9, 2006 |
| K000076 | streck laboratories | CELL-CHEX | March 3, 2000 |
| K940430 | medical specialties intl | SEDRATROL | February 6, 1995 |
| K900484 | streck laboratories | RET-CHECK | March 9, 1990 |