FDA product code GLG: Platelet Counting, Manual
GLG is the FDA product code for platelet counting, manual. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under GLG, from 3 different applicants. The average 510(k) review took 53 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Platelet Counting, Manual |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GLG clearance
Top GLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-07 |
| Labtronix Corp. | 1 | 1981-07-23 |
| Streck Laboratories, Inc. | 1 | 1977-11-30 |
Most recent GLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842921 | E K Ind., Inc. | REES & ECKER DILUTION FLUID | 1984-09-07 | 44 |
| K811084 | Labtronix Corp. | LABTRONIX PLATELET COUNTER(L/O/C.) | 1981-07-23 | 93 |
| K772105 | Streck Laboratories, Inc. | PLATELET KIT | 1977-11-30 | 23 |
Recalls for GLG devices
openFDA lists no recalls for product code GLG.
Frequently asked questions
What is FDA product code GLG?
GLG is the FDA product code for platelet counting, manual. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GLG?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GLG?
Across 3 cleared submissions the average was 53 days from receipt to decision (median 44).
Which companies have the most GLG clearances?
E K Ind., Inc. (1); Labtronix Corp. (1); Streck Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLG
- Run a recall and safety report across every GLG manufacturer
- Watch product code GLG 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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