GLE
5 FDA 510(k) clearances · Product code
30 daysmedian time to decision
66 days90th percentile
5clearances measured
FDA profile
- Official device name
- Mixer, Blood Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Medical specialty
- Clinical Chemistry
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMS HEMATOLOGY MIXER (K823124) | Innovative Medical Systems, Inc. | 1982-11-22 |
| CORTEX DOUBLE HELIX SAMPLER (K800003) | Cortex Research Corp. | 1980-02-01 |
| DISC-PAK ROTATOR (K780544) | Techhnilab Instruments, Inc. | 1978-04-24 |
| SPECI-MIX (K771617) | Thermolyne Corp. | 1977-09-02 |
| PLATELET AGITATOR (K770830) | Helmer Labs, Inc. | 1977-07-11 |
Track GLE automatically
Every clearance here is in the API, with alerts when new ones post.