FDA Product Code
FDA Product Code GLE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2050
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K823124 | IMS HEMATOLOGY MIXER | Innovative Medical Systems, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K800003 | CORTEX DOUBLE HELIX SAMPLER | Cortex Research Corp. | 1980-02-01 | Traditional | PDF ↗ |
| K780544 | DISC-PAK ROTATOR | Techhnilab Instruments, Inc. | 1978-04-24 | Traditional | PDF ↗ |
| K771617 | SPECI-MIX | Thermolyne Corp. | 1977-09-02 | Traditional | PDF ↗ |
| K770830 | PLATELET AGITATOR | Helmer Labs, Inc. | 1977-07-11 | Traditional | PDF ↗ |
Product code GLE · Class I · Clinical Chemistry. Data: openFDA.