The following data is part of a premarket notification filed by Wallac Oy, A Subsidiary Of Perkinelmer, Inc. with the FDA for Gsp Neonatal Total Galactose Kit.
| Device ID | K133652 |
| 510k Number | K133652 |
| Device Name: | GSP NEONATAL TOTAL GALACTOSE KIT |
| Classification | Enzymatic Methods, Galactose |
| Applicant | WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham, MA 02451 |
| Contact | Jeanette Schier-pugsley |
| Correspondent | Jeanette Schier-pugsley WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. 940 WINTER STREET Waltham, MA 02451 |
| Product Code | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-27 |
| Decision Date | 2014-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147328031 | K133652 | 000 |