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 |