Panels › Clinical Chemistry › Product code PJC · Class 2
Newborn Screening Specimen Collection Paper
Regulation 862.1675
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in PJC
| Company | 510(k)s | Recalls |
|---|---|---|
| PerkinElmer Health Sciences, Inc. | 0 | 2 |
| Agilent Technologies, Inc. | 0 | 1 |
| Perkinelmer, Inc. | 1 | 0 |
| Whatman Specialty Products, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2017 | PerkinElmer Health Sciences, Inc. PerkinElmer 226 Sample Collection Device Terminated |
PJC | K121864 |
| Jul 24, 2017 | PerkinElmer Health Sciences, Inc. 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 Newbo Terminated |
PJC | K121864 |
| Jun 17, 2015 | Agilent Technologies, Inc. Bond Elut OMS (Dried Matrix Spotting)' Product;
Catalog model numbers:
5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk;
A400150 - Bond Elut EMS Card 50/Pk;
A400150K - Bond Elut DMS Card BULK 50 Terminated |
PJC | None listed |
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