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 |