FDA product code GLE: Mixer, Blood Tube
GLE is the FDA product code for mixer, blood tube. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under GLE, from 5 different applicants. The average 510(k) review took 31 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Mixer, Blood Tube |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every GLE clearance
Top GLE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Medical Systems, Inc. | 1 | 1982-11-22 |
| Cortex Research Corp. | 1 | 1980-02-01 |
| Techhnilab Instruments, Inc. | 1 | 1978-04-24 |
| Thermolyne Corp. | 1 | 1977-09-02 |
| Helmer Labs, Inc. | 1 | 1977-07-11 |
Most recent GLE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823124 | Innovative Medical Systems, Inc. | IMS HEMATOLOGY MIXER | 1982-11-22 | 31 |
| K800003 | Cortex Research Corp. | CORTEX DOUBLE HELIX SAMPLER | 1980-02-01 | 30 |
| K780544 | Techhnilab Instruments, Inc. | DISC-PAK ROTATOR | 1978-04-24 | 21 |
| K771617 | Thermolyne Corp. | SPECI-MIX | 1977-09-02 | 9 |
| K770830 | Helmer Labs, Inc. | PLATELET AGITATOR | 1977-07-11 | 66 |
Recalls for GLE devices
openFDA lists no recalls for product code GLE.
Frequently asked questions
What is FDA product code GLE?
GLE is the FDA product code for mixer, blood tube. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is GLE?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GLE?
Across 5 cleared submissions the average was 31 days from receipt to decision (median 30).
Which companies have the most GLE clearances?
Innovative Medical Systems, Inc. (1); Cortex Research Corp. (1); Techhnilab Instruments, Inc. (1); Thermolyne Corp. (1); Helmer Labs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLE
- Run a recall and safety report across every GLE manufacturer
- Watch product code GLE 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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