FDA product code GLQ: Mixture, Control, White-Cell And Red-Cell Indices
GLQ is the FDA product code for mixture, control, white-cell and red-cell indices. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 10 510(k) submissions under GLQ, from 4 different applicants. The average 510(k) review took 69 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Mixture, Control, White-Cell And Red-Cell Indices |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GLQ clearance
Top GLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck | 4 | 2011-12-22 |
| Streck Laboratories, Inc. | 4 | 2000-04-18 |
| General Diagnostics | 1 | 1983-01-14 |
| Medical Specialties Laboratories | 1 | 1983-01-05 |
Most recent GLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111211 | Streck | CELL-DYN 22 PLUS CONTROL | 2011-12-22 | 237 |
| K110718 | Streck | CELL-CHEX WITH CPPD CRYSTALS | 2011-05-26 | 72 |
| K101335 | Streck | CELL-CHEX | 2010-08-23 | 103 |
| K090137 | Streck | STAK-CHEX PLUS RETICS | 2009-03-18 | 56 |
| K000945 | Streck Laboratories, Inc. | PARA 12 PLUS RETICS | 2000-04-18 | 26 |
Recalls for GLQ devices
openFDA lists no recalls for product code GLQ.
Frequently asked questions
What is FDA product code GLQ?
GLQ is the FDA product code for mixture, control, white-cell and red-cell indices. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GLQ?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GLQ?
Across 10 cleared submissions the average was 69 days from receipt to decision (median 45).
Which companies have the most GLQ clearances?
Streck (4); Streck Laboratories, Inc. (4); General Diagnostics (1); Medical Specialties Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLQ
- Run a recall and safety report across every GLQ manufacturer
- Watch product code GLQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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