PJC · Newborn Screening Specimen Collection Paper
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | PJC |
|---|---|
| Device Name | Newborn Screening Specimen Collection Paper |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | Perkinelmer, Inc. | Mar 12, 2013 | SESE |
| K932661 | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 | Whatman Specialty Products, Inc. | Apr 17, 1996 | SESE |
Top Applicants
- Perkinelmer, Inc. — 1 clearance
- Whatman Specialty Products, Inc. — 1 clearance
