510(k) K121864
- Device
- PERKINELMER 226 SAMPLE COLLECTION DEVICES
- Applicant
- PERKINELMER, INC.
- 510(k) number
- K121864
- Product code
- PJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-12
- Date received
- 2012-06-26
- Regulation
- 862.1675
- Classification name
- Newborn Screening Specimen Collection Paper
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAY A TAYLOR
- Address
- 17 P&N Dr. Greenville SC US 29611 29611
FDA Registration Numbers#
- 2020726
- 3007145015
Source Documents#
Other 510(k) Records For Product Code PJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932661 | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 | Whatman Specialty Products, Inc. | 1996-04-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary