GLE — Mixer, Blood Tube Class I
FDA product code GLE covers "Mixer, Blood Tube", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GLE
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823124 | innovative medical systems | IMS HEMATOLOGY MIXER | November 22, 1982 |
| K800003 | cortex research | CORTEX DOUBLE HELIX SAMPLER | February 1, 1980 |
| K780544 | techhnilab instruments | DISC-PAK ROTATOR | April 24, 1978 |
| K771617 | thermolyne | SPECI-MIX | September 2, 1977 |
| K770830 | helmer labs | PLATELET AGITATOR | July 11, 1977 |