K121864 is an FDA 510(k) clearance for the PERKINELMER 226 SAMPLE COLLECTION DEVICES. This device is classified as a Newborn Screening Specimen Collection Paper (Class II - Special Controls, product code PJC).
Submitted by Perkinelmer, Inc. (Greenville, US). The FDA issued a Cleared decision on March 12, 2013, 259 days after receiving the submission on June 26, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675. 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..
| 510(k) Number | K121864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2012 |
| Decision Date | March 12, 2013 |
| Days to Decision | 259 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PJC - Newborn Screening Specimen Collection Paper |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
| Definition | 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. |