Whatman Body Fluid Collection Paper:Whatman BFC180
FDA 510(k) K932661 · Whatman Specialty Products, Inc.
510(k) numberK932661
Submission
- Device name
- Whatman Body Fluid Collection Paper:Whatman BFC180
- Applicant
- Whatman Specialty Products, Inc.
Fairfield, NJ, US - Received
- June 2, 1993
- Decision date
- April 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PJC – Newborn Screening Specimen Collection Paper
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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.
Other 510(k)s with product code PJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121864 | Perkinelmer 226 Sample Collection DevicesPJC · Abbreviated | Perkinelmer, Inc. | 03/12/2013SE |
Questions and answers
When was Whatman Body Fluid Collection Paper:Whatman BFC180 cleared by the FDA?
Whatman Body Fluid Collection Paper:Whatman BFC180 (K932661) received a 510(k) decision of Substantially Equivalent on April 17, 1996, 1,050 days after the submission was received.
What is the product code of K932661?
The FDA product code is PJC – Newborn Screening Specimen Collection Paper, a Class II (moderate risk) device regulated under 21 CFR 862.1675.