PERKINELMER 226 SAMPLE COLLECTION DEVICES— 510(k) K121864
Substantially EquivalentPerkinelmer, Inc.
FDA 510(k) clearance K121864 for PERKINELMER 226 SAMPLE COLLECTION DEVICES, Substantially Equivalent on 2013-03-12. Applicant: Perkinelmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Perkinelmer, Inc.
- Product code
- Code PJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Greenville, SC, US
Recent devices under product code PJC
view allMore clearances from Perkinelmer, Inc.
view allRecalls naming K121864
K-number listed on FDA's recall record- Z-2264-2020 — PerkinElmer 226 Sample Collection Device
- Z-2756-2017 — PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
- Z-0030-2014 — Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121864.
Data sourced from openFDA. This site is unofficial and independent of the FDA.