Product code GLE— Clinical Chemistry

FDA has cleared 5 devices under product code GLE between 1977 and 1982, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19821 clearance
• 19801 clearance
• 19781 clearance
• 19772 clearances

• Thermolyne Corp.1 clearance
• Techhnilab Instruments, Inc.1 clearance
• Innovative Medical Systems, Inc.1 clearance
• Helmer Labs, Inc.1 clearance
• Cortex Research Corp.1 clearance

• K823124 — IMS HEMATOLOGY MIXERInnovative Medical Systems, Inc.·1982-11-22
• K800003 — CORTEX DOUBLE HELIX SAMPLERCortex Research Corp.·1980-02-01
• K780544 — DISC-PAK ROTATORTechhnilab Instruments, Inc.·1978-04-24
• K771617 — SPECI-MIXThermolyne Corp.·1977-09-02
• K770830 — PLATELET AGITATORHelmer Labs, Inc.·1977-07-11