Medical Device Manufacturer · US , Pittsburgh , PA

Agilent Technologies, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1985

Recent clearances: GenetiSure Dx Postnatal Assay, MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A, AGILENT M2636B TELEMON B MONITOR (TELEMON B)

30
Total
30
Cleared
0
Denied

Agilent Technologies, Inc. is an American global company that provides instruments, software, services, and consumables for laboratories. Headquartered in Santa Clara, California, Agilent was established in 1999 as a spin-off from Hewlett-Packard.

The company has received 30 FDA 510(k) clearances from 30 total submissions. Cardiovascular devices represent the dominant focus, accounting for approximately 80% of regulatory submissions. Agilent's FDA 510(k) clearance history spans from 1985 to 2017, establishing a long track record in medical device regulation.

Notable cleared devices include defibrillator/monitor systems, telemetry monitors, and diagnostic assays for medical genetics. These products reflect Agilent's expertise in cardiovascular monitoring and clinical diagnostics.

This company profile represents a historical regulatory record. Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Tuv Product Service, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Agilent Technologies, Inc.

30 devices
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