Panels › Clinical Chemistry › Product code GLE · Class 1
Mixer, Blood Tube
Regulation 862.2050
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GLE
| Company | 510(k)s | Recalls |
|---|---|---|
| Cortex Research Corp. | 1 | 0 |
| Helmer Labs, Inc. | 1 | 0 |
| Innovative Medical Systems, Inc. | 1 | 0 |
| Techhnilab Instruments, Inc. | 1 | 0 |
| Thermolyne Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 1982 | K823124 | IMS HEMATOLOGY MIXER Innovative Medical Systems, Inc. | GLE |
| Feb 1, 1980 | K800003 | CORTEX DOUBLE HELIX SAMPLER Cortex Research Corp. | GLE |
| Apr 24, 1978 | K780544 | DISC-PAK ROTATOR Techhnilab Instruments, Inc. | GLE |
| Sep 2, 1977 | K771617 | SPECI-MIX Thermolyne Corp. | GLE |
| Jul 11, 1977 | K770830 | PLATELET AGITATOR Helmer Labs, Inc. | GLE |
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