PJC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Newborn Screening Specimen Collection Paper
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Medical specialty
- Clinical Chemistry
- FDA definition
- Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PERKINELMER 226 SAMPLE COLLECTION DEVICES (K121864) | Perkinelmer, Inc. | 2013-03-12 |
| WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661) | Whatman Specialty Products, Inc. | 1996-04-17 |
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