GLE · Mixer, Blood Tube
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | GLE |
|---|---|
| Device Name | Mixer, Blood Tube |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| GMP Exempt | Yes |
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823124 | IMS HEMATOLOGY MIXER | Innovative Medical Systems, Inc. | Nov 22, 1982 | SESE |
| K800003 | CORTEX DOUBLE HELIX SAMPLER | Cortex Research Corp. | Feb 1, 1980 | SESE |
| K780544 | DISC-PAK ROTATOR | Techhnilab Instruments, Inc. | Apr 24, 1978 | SESE |
| K771617 | SPECI-MIX | Thermolyne Corp. | Sep 2, 1977 | SESE |
| K770830 | PLATELET AGITATOR | Helmer Labs, Inc. | Jul 11, 1977 | SESE |
Top Applicants
- Cortex Research Corp. — 1 clearance
- Helmer Labs, Inc. — 1 clearance
- Innovative Medical Systems, Inc. — 1 clearance
- Techhnilab Instruments, Inc. — 1 clearance
- Thermolyne Corp. — 1 clearance
