The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Perkinelmer 226 Sample Collection Devices.
| Device ID | K121864 |
| 510k Number | K121864 |
| Device Name: | PERKINELMER 226 SAMPLE COLLECTION DEVICES |
| Classification | Newborn Screening Specimen Collection Paper |
| Applicant | PERKINELMER, INC. 17 P&N DRIVE Greenville, SC 29611 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor PERKINELMER, INC. 17 P&N DRIVE Greenville, SC 29611 |
| Product Code | PJC |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-26 |
| Decision Date | 2013-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60812589020018 | K121864 | 000 |
| 50812589020011 | K121864 | 000 |
| 40812589020014 | K121864 | 000 |
| 30812589020017 | K121864 | 000 |
| 20812589020010 | K121864 | 000 |