Perkinelmer, Inc.
Perkinelmer, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2022, with 2 FDA device recalls on record.
Top product codes for Perkinelmer, Inc.
FDA recalls by Perkinelmer, Inc.
- Z-0780-2017 — PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS
- Z-0747-2017 — Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Perkinelmer, Inc.
- DEN200044 — Eonis SCID-SMA Kit
- K203035 — Eonis SCID-SMA kit
- K193103 — NeoBase 2 Non-derivatized MSMS Kit
- DEN180056 — GSP Neonatal Creatine Kinase - MM kit
- K190335 — GSP Neonatal Total Galactose kit
- K190266 — NeoLSD MSMS Kit
- K161966 — PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
- K161942 — PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
- K142698 — PerkinElmer, XRpad 4343 F MED Flat Panel Detector
- K140551 — PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
- K121864 — PERKINELMER 226 SAMPLE COLLECTION DEVICES
- K122495 — PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
- K093916 — NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
- K100101 — GSP NEONATALGALT KIT, MODEL 3303-001U
- K090123 — NEONATAL BIOTINIDASE KIT, MODEL 3018
- K090846 — GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
- K083130 — NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
Data sourced from openFDA. This site is unofficial and independent of the FDA.