510(k) K932661
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1996
- Date Received
- June 2, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Newborn Screening Specimen Collection Paper
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
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.