GLQ — Mixture, Control, White-Cell And Red-Cell Indices Class II
FDA product code GLQ covers "Mixture, Control, White-Cell And Red-Cell Indices", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GLQ
- 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 |
|---|---|---|---|
| K111211 | streck | CELL-DYN 22 PLUS CONTROL | December 22, 2011 |
| K110718 | streck | CELL-CHEX WITH CPPD CRYSTALS | May 26, 2011 |
| K101335 | streck | CELL-CHEX | August 23, 2010 |
| K090137 | streck | STAK-CHEX PLUS RETICS | March 18, 2009 |
| K000945 | streck laboratories | PARA 12 PLUS RETICS | April 18, 2000 |
| K994388 | streck laboratories | XE CHECK | January 14, 2000 |
| K992887 | streck laboratories | STAK-CHEX PLUS RETICS | November 22, 1999 |
| K823794 | general diagnostics | CONTROL TM 8 | January 14, 1983 |
| K823587 | medical specialties laboratories | UNI-CELL | January 5, 1983 |
| K823498 | streck laboratories | PARA 12 | December 28, 1982 |