The following data is part of a premarket notification filed by Wallac Oy with the FDA for Gsp Neonatal Biotinidase Kit.
| Device ID | K131284 |
| 510k Number | K131284 |
| Device Name: | GSP NEONATAL BIOTINIDASE KIT |
| Classification | System, Test, Biotinidase |
| Applicant | WALLAC OY 940 WINTER STREET Waltham, MA 02451 |
| Contact | Jeanette Schier-pugsley |
| Correspondent | Jeanette Schier-pugsley WALLAC OY 940 WINTER STREET Waltham, MA 02451 |
| Product Code | NAK |
| CFR Regulation Number | 862.1118 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147330911 | K131284 | 000 |