The following data is part of a premarket notification filed by Wallac Oy with the FDA for Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 And 3029-110b.
| Device ID | K071649 |
| 510k Number | K071649 |
| Device Name: | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B |
| Classification | Enzymatic Methods, Galactose |
| Applicant | WALLAC OY 940 WINTER STREET Waltham, MA 02451 |
| Contact | Cindy Lloyd |
| Correspondent | Cindy Lloyd WALLAC OY 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 | 2007-06-18 |
| Decision Date | 2008-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147275281 | K071649 | 000 |