GGL — Control, White-Cell Class II
FDA Device Classification
Classification Details
- Product Code
- GGL
- 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 |
|---|
| K083926 | streck | CD4 COUNT | February 11, 2009 |
| K051633 | streck | CD-CHEX PLUS BC | August 16, 2005 |
| K993126 | streck laboratories | CD-CHEX CD 34 | November 26, 1999 |
| K960894 | streck laboratories | CD-CHEX + RBC | May 24, 1996 |
| K931825 | streck laboratories | CD-CHEX CD4 LOW | June 6, 1994 |
| K920997 | streck laboratories | CD-CHEX | May 31, 1992 |
| K894651 | coulter | COULTER POSITIVE CONTROL CELLS | September 13, 1989 |
| K891175 | elite diagnostic | EDL ABNORMAL COAGULATION CONTROL | April 10, 1989 |