510(k) K932661
K932661 is an FDA 510(k) premarket notification submitted by Whatman Specialty Products, Inc. for the device "WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180". The FDA issued a decision of Substantially Equivalent on April 17, 1996. The device falls under product code PJC (Newborn Screening Specimen Collection Paper), a Class II device regulated under 21 CFR 862.1675.
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.