GLE · Class I · 21 CFR 862.2050

FDA Product Code GLE: Mixer, Blood Tube

Leading manufacturers include Helmer Labs, Inc., Thermolyne Corp. and Techhnilab Instruments, Inc..

5
Total
5
Cleared
31d
Avg days
1977
Since

FDA 510(k) Cleared Mixer, Blood Tube Devices (Product Code GLE)

5 devices
1–5 of 5
Cleared Nov 22, 1982
IMS HEMATOLOGY MIXER
K823124
Innovative Medical Systems, Inc.
Hematology · 31d
Cleared Feb 01, 1980
CORTEX DOUBLE HELIX SAMPLER
K800003
Cortex Research Corp.
Hematology · 30d
Cleared Apr 24, 1978
DISC-PAK ROTATOR
K780544
Techhnilab Instruments, Inc.
Hematology · 21d
Cleared Sep 02, 1977
SPECI-MIX
K771617
Thermolyne Corp.
Hematology · 9d
Cleared Jul 11, 1977
PLATELET AGITATOR
K770830
Helmer Labs, Inc.
Hematology · 66d

About Product Code GLE - Regulatory Context