Perkinelmer, Inc. - FDA 510(k) Cleared Devices

Perkinelmer, Inc. is a global provider of laboratory instruments, reagents, and analytical solutions. The company operates with a manufacturing facility in Indianapolis, US, and specializes in chemistry devices for clinical diagnostics and research applications.

PerkinElmer received 15 FDA 510(k) clearances from 17 total submissions between 2009 and 2022. The company's cleared devices focus primarily on neonatal screening and mass spectrometry chemistry kits, along with diagnostic instrumentation. This regulatory record reflects the company's established presence in clinical laboratory testing.

The company's FDA 510(k) cleared portfolio includes neonatal metabolic screening kits, tandem mass spectrometry assays, and sample collection devices. A single radiology device clearance indicates broader analytical instrumentation capabilities beyond chemistry-focused products.

PerkinElmer has not submitted new 510(k) applications since 2022 and is maintained as a historical regulatory record. Explore the complete list of device names, product codes, and clearance dates in the database.