Mixer, Blood Tube
The Blood Tube Mixer is a laboratory device used in clinical chemistry to gently mix blood specimens in collection tubes, preventing clotting and ensuring homogeneous samples before analysis. It is classified as FDA Class 1 (lowest risk), meaning it is subject only to general controls and does not require premarket notification. The product code is GLE, regulated under 21 CFR 862.2050 in the Clinical Chemistry specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- GLE
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823124 | IMS HEMATOLOGY MIXER | Nov 22, 1982 | Substantially Equivalent | Innovative Medical Systems, Inc. |
| K800003 | CORTEX DOUBLE HELIX SAMPLER | Feb 01, 1980 | Substantially Equivalent | Cortex Research Corp. |
| K780544 | DISC-PAK ROTATOR | Apr 24, 1978 | Substantially Equivalent | Techhnilab Instruments, Inc. |
| K771617 | SPECI-MIX | Sep 02, 1977 | Substantially Equivalent | Thermolyne Corp. |
| K770830 | PLATELET AGITATOR | Jul 11, 1977 | Substantially Equivalent | Helmer Labs, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.