The following data is part of a premarket notification filed by Wallac Oy, Subsidiary Of Perkinelmer with the FDA for Gsp Neonatal Irt Kit (3306-001u).
| Device ID | K102419 |
| 510k Number | K102419 |
| Device Name: | GSP NEONATAL IRT KIT (3306-001U) |
| Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Applicant | WALLAC OY, SUBSIDIARY OF PERKINELMER 940 WINTER STREET Waltham, MA 02451 |
| Contact | Susan K Hamann |
| Correspondent | Susan K Hamann WALLAC OY, SUBSIDIARY OF PERKINELMER 940 WINTER STREET Waltham, MA 02451 |
| Product Code | JNO |
| CFR Regulation Number | 862.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-25 |
| Decision Date | 2010-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147320523 | K102419 | 000 |